SOP-2099 v03 - Guidance to Chromatographic Analytical Method Development 層析分析方法開發指引

Doc.
Number: SOP-2099 Revision: 03 Effective Date: 27 Jan 2023
Guidance to Chromatographic Analytical Method Development

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層析分析方法開發指引
PURPOSE 目的
The purpose of this document is to provide a guideline for method development of general chromatographic
test methods.
本文件的目的是為了提供指引去開發層析分析方法。
SCOPE 範圍
This SOP applies to all the chromatographic test methods for raw materials and finished products developed in
Analytical R&D department. It serves as an informative guidance and applies to all personnel that support the
execution of analytical method development activities. Some studies specified in this SOP may vary or be
exempted depending on the nature of the method.
本標準作業程序適用分析研發部門去開發所有原料及成品的層析分析方法，對執行開發分析方法的人員提供指
導。本標準作業程序中一些所指定的研究，可能會根據方法的性質而有所不同或者免除。
REFERENCE 參考文件
REFERENCE TITLE
ICH Guideline Q2 Validation of Analytical Procedures: Text and Methodology
(R1)
ICH Guideline Impurities in New Drug Substances

Q3A (R2)
ICH Guideline Impurities in New Drug Products

Q3B (R2)
ICH Guideline Guideline of Residual Solvents

Q3C (R8)
Current USP <1225> / <1226>
KTA-2099 Knowledge Transfer Assessment (KTA) Standards

知識移轉評估（KTA）標準
DEFINITIONS/ABBREVIATIONS 定義/縮寫
TERM DEFINITION
Specificity The ability to assess unequivocally the analyte in the presence of components that may
專一性 be expected to be present, such as impurities, degradants, and matrix components.
確認一些可能存在於分析物中的物質，如不純物、降解物與基質成分，從而對分析物質作
出可靠的測定。
System Suitability Process of ensuring that the entire system is in a controlled state prior to and during the
系統適用性 analysis.
確保整個系統在分析前及過程中是處於受控制狀態。
Printed by: Printed Date: 24 Jul 2023

Doc. Number: SOP-2099 Revision: 03 Effective Date: 27 Jan 2023

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TERM DEFINITION
Precision Expresses the closeness of agreement between a series of measurements obtained from
精密度 multiple samplings of the same homogeneous sample.
從相同均質樣品中多次取樣進行一系列檢測結果的一致性程度。
Accuracy Expresses the closeness of agreement between the value which is accepted either as a
準確度 conventional true value or and accepted reference value and the value found (percent
recovery).
真值或認可的參考值與測量值（回收率）之間的一致性程度。
Robustness A measure of a method’s capability to remain unaffected by small but deliberate variations
耐變性 in analytical method parameters.
分析方法參數適當地微調改變時，其測量能力保持不受影響。
Detection/ The lowest amount of analyte in a sample that can be detected/quantitatively determined
Quantitation Limit with suitable accuracy and precision.
偵測/定量極限在具有合適的準確度和精密度的條件下，樣品中的分析物質能夠被偵測/定量的最低量。
Linearity Determine the linear range of the method by measuring the linear regression, e.g., R2 and
線性 intercept.
透過測量線性回歸獲得之參數如 R2、截距，確定該方法的線性範圍。
PROCEDURES 程序
Procedure Responsibility
5.1 Method Development and Evaluation Analyst
方法開發及評估
5.1.1 Analytical Methods are typically developed via the following workflow:
以下是分析方法開發的流程：
 Determine the test objective/test type
確定測試目標/測試類型
 Literature search and review
文獻檢索和審查
 Preliminary experimental development and method evaluation
初步實驗開發及方法評估
 Impurities assessment and determination
不純物評估和確定
 Evaluation of method robustness
方法耐變性的評估
 Evaluation of method performance
方法性能的評估
5.1.2 Based on the intended use of the Method, Establish and Determine the applicable test
type as follows:
基於方法的目的，建立和確定合適的測試類型，如下所示：
 Identification test
鑑別試驗


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 Quantitative test of active moiety in drug substance or drug product Analyst
原料藥或產品之活性成份的定量檢測
 Quantitative test of impurity content
不純物的定量檢測
 Limit test for the control of impurities
不純物的限量測試
5.1.3 Perform a literature search to assist in the characterization of the chemical and
physical properties of the analytes, known degradation products, and excipients if
applicable.
檢索文獻以理解分析物、已知降解產物和賦形劑（如適用）的化學和物理性質和特徵。
5.1.3.1 Review the manufacturer’s technical package for the needed chromatographic test
methods and validation including forced degradation study results, if available. Also
study the drug’s chemical properties such as structures, molecular structure/weight,
analyte pKa, UV spectra, molecular stability, solubility and impurities profile etc.
查看製造商的技術方案所需要的層析測試方法和確效，如可用時，包括強制降解的研究
結果。研究該藥物的化學特性，如結構、分子結構（分子量）、分析物的 pKa、紫外吸
收光譜、分子穩定性、溶解度和不純物試驗等。
5.1.3.2 Obtain the reference standard, drug substance sample and related impurities from the
USP/EP and manufacturer with their certificate of analysis if available. Check for any
missing information such as method validation, column, HPLC parameters, and make a
request from the manufacturer if necessary.
從 USP/EP 或製造商取得的參考標準品、原料藥樣品及相關不純物，如有提供則要取得
分析證書(CoA)。檢查是否有任何欠缺的資料，如方法確效、層析管柱、HPLC 參數，如
果需要，向製造商請求相關資訊。
5.1.3.3 Search for any existing compendial methods (i.e., PF, USP or EP), other available
literatures and technical resources (e.g., Merck Index) for reference.
檢索任何現有藥典方法（即 PF、USP 或 EP），其他可用的文獻和技術資源（例如，默
克索引），以供參考。
5.1.4 Preliminary Experimental Development

初步試驗性的開發
5.1.4.1 For the impurity test of drug substance, if the manufacturer claims more impurities than
in the compendial method and the compendial method is not suitable for its intended
use, follow the test method from the manufacturer. A comparison study of an impurity
test on same lot of sample should be performed to justify the method equivalence or
superiority.
對於原料藥樣品的不純物測試，如果製造商聲稱的不純物比藥典方法多，且藥典方法不
適合其擬定用途。則必須按照製造商的測試方法，對同一批樣品進行不純物測試，並與
藥典方法比對，來證明方法相等性或優越性。
5.1.4.2 If the drug substance is not listed in the compendial method, follow the manufacturer’s
test method. If there is difficulty utilizing the manufacturer’s method, a modification or
an in-house developed method may be applied. Document the change and justification
and discuss the issue with the manufacturer if necessary.


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如果原料藥沒有列在藥典方法中，則按照製造商的方法測試。如果在使用製造商的方法 Analyst
出現困難時，可修改之或開發內部方法。記錄過程中的改變和改變的理由，有需要時可
與製造商討論相關議題。
5.1.4.3 For the test method of drug product, if the compendial method is not suitable for its
intended use, a modification or an in-house method may be applied. A comparison
study should be performed for the justification. If there is no compendial method, an
in-house method may be developed based on drug substance test method, forced
degradation study, or pertinent literatures.
對於藥物產品的測試方法，如果藥典方法不適合其預定用途，可修改之或開發內部方
法。修改部份可與藥典進行對比，並記錄修改的理由。如果沒有藥典方法，內部方法開
發可以用依照原料藥樣品的測驗方法、強制降解研究或是相關文獻為基礎。
5.1.5 Preliminary method evaluation on the following typical method attributes is listed
below. The items may vary depending on the nature of the method
初步的方法評估可依照下列典型方法的驗證項目，其會因方法的性質而有所改變。
 Specificity
專一性
 System suitability
系統適用性
 Precision
精密度
 Accuracy
準確度
 Robustness
耐變性
 Detection/Quantitation Limit
偵測（定量）極限
 Linearity
線性
 Solution Stability
溶液安定性
 Filter Interference
過濾器干擾


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5.2 Method Development Procedure Analyst
方法開發的程序
5.2.1 Based on the method attributes above the typical studies and requirements when
performing method development are included but not limited to given below in the
following sections. Utilizing these procedures may help ensure the method is
validatable. Some other studies such as solubility, solution stability, filter interference
etc. are also included for its intended use. However, depending on the method origin
and requirements, these studies may vary from product to product but should be
documented in the notebook.
在進行方法開發時可以包括以上方法驗證項目及要求，但不限於以下的章節。利用這些
方法開發程序可以確保方法是可確效的。還包括其他研究，如溶解度、溶液穩定性、過
濾器干擾等，以達到原先擬定用途。然而，根據方法本身和要求，研究方案可能因不同
產品而有所不同，應記錄在筆記本上。
5.2.2 The detailed method development procedure is tabulated in Appendixes 1 - 7.

詳細的方法開發程序列在附錄 1 至 7。
5.3 Documentation for Method Development

方法開發的文件記錄
5.3.1 Document all method development activities such as experimental procedures and
results in the lab notebooks. Include photocopies of chromatograms, excel
spreadsheets, and certificate of analysis if applicable.
所有方法的開發活動如實驗過程和結果必須記錄在實驗筆記本內。當中包括層析譜圖影
本，Excel 電子表格和分析證書（如適用時）。
5.3.2 The method development data is subject to peer review for technical merit,
completeness, and accuracy prior to the initiation of validation.
方法開發數據及結果必須進行內部審核，以取得技術上的指標、完整性和準確性，才進
行完整的驗證程序。
5.3.3 Archive all relevant data packages, keep all the information for authorizing the methods
and analytical development plans or reports.
把所有相關的數據收集整合，用以核准分析方法、分析開發計劃或報告。
5.4 Knowledge Transfer Assessment (KTA) Standards All Users

知識移轉評估（KTA）標準
Provide KTA to employees to test their knowledge of the SOP. KTA testing can be
used for the SOP self-training assessment.
將知識移轉評估提供給員工以評估他們對本 SOP 的認知，知識移轉評估可適用於 SOP
個人訓練紀錄。


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Appendix 1 - For Assay Test of Drug Substance

Typical Method Attribute Evaluation Methodology
Specificity Inject the blank solution, API and all available impurities to ensure no interference
to the API peak.
 Resolution, between peaks ≥ 1.5
Solubility Check the API solubility in diluent or extraction solvent. The API at the sample
concentration should be completely soluble.
Solution stability The stability of the standard and sample solutions should be established for at
least 1 day. The percent recovery of the sample/standard solutions should be
calculated against freshly prepared standards. The actual stability range may be
specified in the test method if necessary.
 %Recovery relative to T=0
System suitability Ensure the requirements for system suitability such as:
 Injection reproducibility (%RSD for 5 or 6 injections),
 Number of theoretical plates, N
 Tailing factor, T
 Resolution, Rs
 or other required factors are set at appropriate criteria to assure adequate
chromatography can be achieved.
If the result is not satisfactory, investigate the chromatography and find out the
cause (e.g., diluent being a stronger solvent, column overload etc.) and adjust the
method accordingly.
Precision Repeatability:
Test the repeatability of the method on the sample solutions (n ≥ 3). Difference of
NMT 2.0% among the samples is desirable. Generally, attempt to use larger
volume of solvent (≥ 50 mL) and pipette (≥ 5-mL) and larger quantity of standard
and sample (≥ 40 mg). Eliminate the dilution steps to reduce potential analytical
errors if possible.
Robustness Deliberately change some critical method parameters to ensure the method
performance such as system suitability and specificity meet the criteria as
illustrated in this SOP. The typical parameters are:
 ± 5% (relative) of mobile phase composition
 ± 0.1 pH unit
 ± 10% buffer concentration
 ± 2 nm UV wavelength
 ± 5°C column temperature
 ± 10% flow rate
 ± 2°C GC oven temperature; and
 Different lot/batch/manufacturer of analytical columns
Linearity Typically 80–120% of target test concentration. Perform a linear regression
analysis of the peak responses against the concentration.


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Appendix 2 - For Impurity Test of Drug Substance

Specificity Inject the blank solution, API, and all available known impurities to ensure proper
separation for all components. A stress study (e.g., forced degradation) may be
needed to ensure the degradants are free of interference to the API and other
impurities.
 Resolution (Rs) between peaks ≥ 1.5
Solubility Check the solubility of API and known impurities in diluent or extraction solvent.
The API at the sample concentration and the known impurities at target limit
should be completely soluble.
least 1 day if applicable. The percent recovery of the sample/standard solutions
should be calculated against freshly prepared standards. The actual stability
range may be specified in the test method if necessary.
 Injection reproducibility (%RSD for 5 or 6 injections)
 Resolution, Rs
chromatography can be achieved.
cause (e.g., diluent being a stronger solvent, column overload etc.). Adjust the
method accordingly.
Test the repeatability of the method on the sample solutions (n ≥ 3). Evaluate the
closeness of impurity amount for each known impurity and total impurities.
Quantitation limit (QL) Generally the standard is set up at the impurity control limit. The sensitivity test
solution (diluted standard) or QL solution set at about 0.03% is desirable,
however, adjustment can be made to suit for its intended use.
 ± 5% (relative) of mobile phase composition
 ± 0.1 pH unit
Linearity Typically QL (e.g., 0.03%) to 120% of the target limit concentration. Perform linear
regression analysis of the peak responses against the concentrations.
Detection limit (DL) For limit test only. Establish a concentration where S/N ~3
RRF determination Use RRF (Relative response factor) to calculate the impurity amounts where
applicable. Determine the RRF based on either linearity study of API and known
impurities or replicate injections of the known impurities.
System control Check for any extraneous peak, carry over (needle wash), system stability or
other analytical issues.


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Appendix 3 - For Assay Test of Drug Product

Specificity 1) Inject individual or spike all available impurities to the sample to ensure no
interference to the API peak.
2) Forced degradation on API/finished product. Typically with
 Acid (e.g., 0.1 N HCl)
 Base (e.g., 0.1 N NaOH)
 Peroxide (e.g., 0.3% H2O2)
 Heat (e.g., 80°C) and
 Light (UV NLT 200 watt hr/m2)
Use multiple time points to select the proper condition. Do not over-stress such
that the drug degrades over 30%. Check the mass balance to obtain the optimum
condition.
3) Verify the placebo interference including dye and coating material if available.
Accuracy/Recovery Refer to the API and excipient properties or handbook to select proper
diluent/extraction solvent in which API is soluble and tables/seeds can
disintegrate. For example, use methanol as extraction solvent for HPMC based
Oxymorphone ER Tablets because Oxymorphone is soluble and HPMC can
disperse in methanol.
Use larger volume of solvent (≥ 50 mL) and pipette (≥ 5-mL) and larger quantity of
standard and sample (≥ 40 mg).
Try to eliminate grinding/crushing and the dilution steps to reduce potential
analyst’s mistakes if possible.
Spike the API to the placebo equivalent to sample concentration and perform the
extraction for the accuracy test (n ≥ 3).
The recovery should be 100 ± 2.0%.
Precision Test the repeatability of the method on the sample solutions (n ≥ 3).
If the individual potency data differ by more than 3.0%, investigate the analytical
procedure and sample to find out the cause.
Solubility Check the API solubility in diluent or extraction solvent. The API at the sample
least 1 day. The percent recovery of the sample/standard solutions should be
calculated against freshly prepared standards. The actual stability range may be
specified in the test method if necessary.
 Resolution, Rs
chromatography can be achieved
method accordingly.


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Appendix 3 - For Assay Test of Drug Product

(continued)
 ± 2% of mobile phase composition
 ± 0.1 pH unit
Linearity Typically 70–130% of target test concentration. Perform linear regression analysis
of the peak responses against the concentrations.
Filter interference of sample The difference between filtered and unfiltered should be ≤ 2.0%.
solution


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Appendix 4 - For Impurity Test of Drug Product

Specificity 1) Inject individual or spike all available known impurities to the sample to
ensure no interference to each other.
2) If the HPLC condition is not the same as the assay method, perform the
forced degradation on API/finished product, if necessary, placebo also.
Typically with
 Acid (e.g., 0.1 N HCl)
 Base (e.g., 0.1 N NaOH)
 Peroxide (e.g., 0.3% H2O2)
 Heat (e.g., 80°C) and
 Light (UV NLT 200 watt hr/m2), use multiple time points to select the
proper condition
Do not over-stress such that the drug degrades over 30%. Check the mass
balance to obtain the optimum condition.
3) If possible, test a stressed sample, e.g., 60°C 2 weeks, to evaluate the
degradation.
4) Verify the placebo interference including dye and coating material if available.
5) Resolution between peaks ≥ 1.5
Accuracy Refer to the API and excipient properties or handbook to select proper
diluent/extraction solvent in which API is soluble and tables/seeds can
disintegrate. For example, use methanol as extraction solvent for HPMC based
Oxymorphone ER Tablets because Oxymorphone is soluble and HPMC can
disperse in methanol.
Try to eliminate grinding/crushing and the dilution steps to reduce potential
analyst’s mistake if possible.
Spike the API to the placebo equivalent to sample concentration, or if available,
spike the known impurities to the sample solution and perform the extraction for
the accuracy test (n ≥ 3). The recovery evaluation should be based on the spike
level.
Test the repeatability of the method on sample solutions (n ≥ 3). If the impurity
amount differs more than 0.05% for each impurity in the samples, investigate the
analytical procedure and sample to find out the cause.
Quantitation limit (QL) Generally the standard is set up at the impurity control limit. The sensitivity test
solution (diluted standard) or QL solution set at about 0.05% is desirable,
however, adjustment can be made to suit for its intended use.
Solubility Check the solubility of API and known impurities in diluent or extraction solvent.
The API at the sample concentration and the known impurities at target limit
should be completely soluble.


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Appendix 4 - For Impurity Test of Drug Product

(continued)
least 1 day if applicable. The percent recovery of the sample/standard solutions
should be calculated against freshly prepared standards. The actual stability
range may be specified in the test method if necessary.
 Tailing factor
 Resolution, Rs,
chromatography can be achieved
method accordingly.
 ± 0.1 pH unit
Linearity Typically QL (e.g., 0.05%)–120% of standard concentration.
Perform a regression analysis of the peak responses against the standard
concentrations.
Filter interference of the Follow the current SOP or the validation protocol for the criteria.
sample solution
Detection limit (DL) For limit test only. Establish a concentration where S/N ~3
RRF determination Use RRF (Relative response factor) to calculate the impurity amounts where
applicable. Determine the RRF based on either linearity study of API and known
impurities or replicate injections of the known impurities.


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Appendix 5 - For Dissolution Test

Method search Search for any existing compendial methods (i.e., PF, USP, or EP) and FDA
published method (Drugs@FDA, FDA recommended dissolution methods). Follow
these dissolution parameters as a guideline to test this site and reference product.
If there is no information available, or due to different formulation characteristic an
in-house method may substitute with proper documentation.
Method evaluation Check the API solubility in diluent or extraction solvent. The API at the sample
Specificity Analyze the medium and placebo to evaluate the interference (≤ 2% if any) to the
standard.
least 1 day. The percent recovery of the sample/standard solutions calculated
against freshly prepared standards. The actual stability range may be specified in
the test method if necessary.
 Repeatability (%RSD for 5 or 6 injections/readings)
 Number of theoretical plates(for HPLC method), N
 Resolution, Rs, or other required factors are set at appropriate criteria to
assure adequate chromatography can be achieved
cause (e.g., medium effect, improper mobile phase, etc.). Adjust the method
accordingly.
Accuracy Perform the API recovery from the placebo (n ≥ 3) at 10% of lowest and 120% of
highest strength to confirm the accuracy. For example, prepare the API in the
medium at concentration equivalent to 10% of the strength in the required volume
in a vessel. Spike the placebo equivalent to 1 unit into the vessel and proceed the
dissolution as directed. The recovery should be within ± 5% of absolute release.
illustrated in this SOP. Some typical dissolution parameters are:
 ± 2 rpm speed
 ± 0.1 pH unit (media)
 ± 2°C bath temperature
The typical analytical parameters are:
 ± 5% flow rate for HPLC and
 ± 2 nm UV wavelength for UV spectrometer
Linearity Typically 25–120% of target test concentration for Immediate release products; 5–
120% of the highest target test concentration for Extended release products.
Perform a linear regression analysis of the peak responses against the
concentrations.
Filter and tubing interference The difference of ≤ 3% is needed
RRF determination If the drug degrades during the dissolution and the degradant peaks are present
in the chromatogram, use the RRF to calculate the total dissolution amount.


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Appendix 6 - For Residual Solvent Test

Method evaluation Develop the residual solvent based on technical package or USP <467>.
Determine the GC method whether it is analyzed by direct injection or by
headspace. Set up the standard at suitable level, usually at the control limit.
Ensure the sensitivity is adequate to detect lower amount, e.g., 10% of the limit.
Specificity For API method, inject the diluent to ensure no interference to the residual
solvents. For drug product method, inject diluent and placebo to ensure no
interference to the residual solvents.
System suitability Ensure the requirements for system suitability such as injection repeatability
(%RSD for 6 injections) or resolution (if there is) are set at appropriate criteria to
assure adequate chromatography can be achieved. If the result is not satisfactory,
investigate the chromatography and find out the cause (e.g., improper GC or
headspace parameters.). Adjust the method accordingly.
Accuracy Try to select a diluent which can extract the residual solvent out of the API or
excipients efficiently, e.g., DMA, DMF, DMSO or water. Perform the solvent
recovery test (n ≥ 3) at standard level to confirm the accuracy. For example, spike
the System suitability solution (Standard solution) to the sample and proceed the
extraction as directed. The recovery should be between 80–120%. If there is a
matrix effect observed, a standard addition method may be applied.
Precision Reproducibility:
Test the reproducibility of the method on the samples or spiked samples (n ≥ 3). If
the results differ more than 20% among the samples, investigate the analytical
procedure and sample to find out the cause (e.g., insufficient extraction or
equilibration).
 ± 10% GC/headspace flow rate
 ± 2°C GC/head space oven temperature; and
Linearity Typically 10–120% of the standard concentration. Perform a linear regression
analysis of the peak responses against the standard concentrations.


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Appendix 7 - For Cleaning Verification Test

Method evaluation  Develop an HPLC method based on the properties of the API and excipients
and other information.
 Obtain the CV limit, ensure the limit is within linearity range and its S/N is ≥
10.
 In general, prepare 4 µg/mL of the standard solution unless specified
otherwise.
Specificity No peak interference from the diluent and placebo.
Stability Establish swab stability and standard and sample solution stability.
are set at appropriate criteria to assure adequate chromatography can be
achieved.
Accuracy/Recovery Perform the recovery study at two levels to bracket the limit:
For swab recovery:
1) Recovery from the direct spike on the swab vehicle and
2) Recovery from the coupon for evaluation.
For rinse recovery: Recovery from the nozzle spray.
If the recovery is below 50%, different extraction solvent or swab may be
considered.
API stability in detergent The remaining active amount should be ≥ 95% and no peak interference
Linearity At minimum from 50% of the cleaning limit to 200% of the standard concentration.
Perform a linear regression analysis of the responses against the concentrations.
System control Check for any extraneous peak, carry over (needle wash), system stability or other
analytical issues.

List of Changes
Page 1 of 1
變更表
No. SOP-2099 v2.0 SOP-2099 v03 Justification

編號理由
Changed From 變更前 Changed To 變更後
1. Page 1 to the End Page 1 to the End Reduced pages of
Current Format New Format SOP and made the
layout of documents
neater and tidier.
2. N/A Page 1/3.0 Added two
ICH Guideline Q3B (R2): Impurities in New references to align
Drug Products them with the
ICH Guideline Q3C (R8): Guideline of description in this
Residual Solvents SOP.

History of Revisions
Page 1 of 1
改版歷史
Version Change Control No./Summary of Revision Justification

版次變更管制號碼/修訂摘要理由
03 1. Applied new format for SOP. 1. Reduced pages of
2. Added two references in 3.0 REFERENCES. SOP and made the
layout of the
document neater
and tidier.
2. Aligned them with
the description in
this SOP.
2.0 CCR No. PR #1074538 PR #1074538
Change logo, remove company/site name. Company transition
1.0 CCR No. PR #709165 Per CCR No. PR
SOP migration to EDMS system (Electronic Document Management System) #709165 to launch
EDMS system
CCR No. PR #730311
Per CCR No. PR #
SOP format and reference information change
730311 to change the
SOP format and
reference information.

Signature Manifest
Document Number: SOP-2099 Revision: 03
Title: Guidance to Chromatographic Analytical Method Development 層析分析方法開發指引
Effective Date: 27 Jan 2023
All dates and times are in Asia/Taipei.
DCC-004256, SOP-2099 & KTA-2099
SME Review
Name/Signature Title Date Meaning/Reason

Rebecca Chiu (REBECCA.CHIU) 06 Jan 2023, 10:27:59 AM Complete
Sophia Wang (SOPHIA.WANG) 09 Jan 2023, 09:51:28 AM Complete
JyunSiang Fan
19 Jan 2023, 11:19:41 AM Complete & Quit
(JYUNSIANG.FAN)
Yoselin Chen (YOSELIN.CHEN) 19 Jan 2023, 11:30:41 AM Complete
QADC Review

Yuhua Lin (YUHUA.LIN) 19 Jan 2023, 11:55:48 AM Complete
Change Control Approval

Vicky Chiang (VICKY.CHIANG) 19 Jan 2023, 03:31:14 PM Approved
Dept. Approval

Rebecca Chiu (REBECCA.CHIU) 21 Jan 2023, 10:24:27 AM Approved
Customer Approval

Yuhua Lin (YUHUA.LIN) 23 Jan 2023, 05:46:51 PM Approved
QA Approval

Jeff Chang (JEFF.CHANG) 27 Jan 2023, 07:22:51 PM Approved
Set Date

Yuhua Lin (YUHUA.LIN) 27 Jan 2023, 10:05:01 PM Approved
Notify


Yuhua Lin (YUHUA.LIN) 27 Jan 2023, 10:05:02 PM Email Sent
Yoselin Chen (YOSELIN.CHEN) 27 Jan 2023, 10:05:02 PM Email Sent

SOP-2099 v03 - Guidance to Chromatographic Analytical Method Development 層析分析方法開發指引

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Number: SOP-2099 Revision: 03 Effective Date: 27 Jan 2023

Guidance to Chromatographic Analytical Method Development

ICH Guideline Impurities in New Drug Substances

ICH Guideline Impurities in New Drug Products

ICH Guideline Guideline of Residual Solvents

Current USP <1225> / <1226>

KTA-2099 Knowledge Transfer Assessment (KTA) Standards

Printed by: Printed Date: 24 Jul 2023

Guidance to Chromatographic Analytical Method Development

Printed by: Printed Date: 24 Jul 2023

Guidance to Chromatographic Analytical Method Development

5.1.4 Preliminary Experimental Development

Printed by: Printed Date: 24 Jul 2023

Guidance to Chromatographic Analytical Method Development

Printed by: Printed Date: 24 Jul 2023

Guidance to Chromatographic Analytical Method Development

5.2.2 The detailed method development procedure is tabulated in Appendixes 1 - 7.

5.3 Documentation for Method Development

5.4 Knowledge Transfer Assessment (KTA) Standards All Users

Printed by: Printed Date: 24 Jul 2023

Guidance to Chromatographic Analytical Method Development

Appendix 1 - For Assay Test of Drug Substance

Printed by: Printed Date: 24 Jul 2023

Guidance to Chromatographic Analytical Method Development

Appendix 2 - For Impurity Test of Drug Substance

Printed by: Printed Date: 24 Jul 2023

Guidance to Chromatographic Analytical Method Development

Appendix 3 - For Assay Test of Drug Product

Printed by: Printed Date: 24 Jul 2023

Guidance to Chromatographic Analytical Method Development

Appendix 3 - For Assay Test of Drug Product

Printed by: Printed Date: 24 Jul 2023

Guidance to Chromatographic Analytical Method Development

Appendix 4 - For Impurity Test of Drug Product

Printed by: Printed Date: 24 Jul 2023

Guidance to Chromatographic Analytical Method Development

Appendix 4 - For Impurity Test of Drug Product

Printed by: Printed Date: 24 Jul 2023

Guidance to Chromatographic Analytical Method Development

Appendix 5 - For Dissolution Test

Printed by: Printed Date: 24 Jul 2023

Guidance to Chromatographic Analytical Method Development

Appendix 6 - For Residual Solvent Test

Printed by: Printed Date: 24 Jul 2023

Guidance to Chromatographic Analytical Method Development

Appendix 7 - For Cleaning Verification Test

Printed by: Printed Date: 24 Jul 2023

No. SOP-2099 v2.0 SOP-2099 v03 Justification

Printed by: Printed Date: 24 Jul 2023

Version Change Control No./Summary of Revision Justification

Printed by: Printed Date: 24 Jul 2023

DCC-004256, SOP-2099 & KTA-2099

Name/Signature Title Date Meaning/Reason

Name/Signature Title Date Meaning/Reason

Change Control Approval

Name/Signature Title Date Meaning/Reason

Name/Signature Title Date Meaning/Reason

Name/Signature Title Date Meaning/Reason

Name/Signature Title Date Meaning/Reason

Name/Signature Title Date Meaning/Reason

Printed by: Printed Date: 24 Jul 2023

Name/Signature Title Date Meaning/Reason