3.2.P.4.1 Excipients

Bevacizumab (400mg/16mL, Single use vial)
3. MODULE 3
3.1 Table of Contents
3.2.P DRUG PRODUCT (BEVACIZUMAB, HETERO BIOPHARMA LIMITED) ............................ 2
3.2.P.4 Control of Excipients (Bevacizumab, solution for injection in vial (400 mg/
16mL)……………………………………………………………………………………………………..….2
3.2.P.4.1 Specifications (Bevacizumab, solution for injection in vial (400 mg/ 16mLs) ................................ 2
List of Tables
Table 1: Excipients used in formulation of Hetero bevacizumab DP (400 mg / 16mL) ......................................... 2
Table 2: List of the test methods and respective specifications for the Hetero bevacizumab DP excipients .......... 3
3.2.P.4.1 Excipients
Confidential Page 1 of 6
3.2.P DRUG PRODUCT (BEVACIZUMAB, HETERO BIOPHARMA LIMITED)

3.2.P.4 Control of Excipients (Bevacizumab, solution for injection in vial (400 mg/
16mL)
The excipients chosen, their concentration, and the characteristics can influence the drug
product (DP) performance (e.g., stability). Hetero bevacizumab formulation buffer is based on
the reference medicinal product (RMP; Avastin®) formulation. All the excipients used are same
as that of Avastin® and are of multi-pharmacopoeial grade. As per regulatory expectations,
being infusion solutions, no antimicrobial agent or preservatives have been added.
As excipients can affect the final product quality, stability, the control of excipients forms an
important part of DP control strategy. The control of excipients through specifications and
quality control (QC) tests has been outlined in this section.
3.2.P.4.1 Specifications (Bevacizumab, solution for injection in vial (400 mg/ 16mL)
Bevacizumab drug product single use vial 400 mg/16mL (Oncology use) formulation is based
on that of Avastin®. The unit composition of Hetero bevacizumab drug product and functions
of excipients have been included in the section 3.2.P.1. Bevacizumab drug product excipients
along with their grades and representative batch formula have been summarized in the
following Table.
Table 1: Excipients used in formulation of Hetero bevacizumab DP (400 mg / 16mL)
Batch formula: Quantity per Batch (g) for
8L scale
Quantit
Quantity BB1601 BB1701
Ingredient Grade Manufacturers y per BB1702 M
per mL
Unit Mfg date: Mfg date: fg date: Mar
Nov 2016 Mar 2017 2017
Bevacizumab HBL
In-House 400 mg 25 mg 200 g 200 g 200 g
(r-DNA origin) (active ingredient)
α,α-Trehalose J.T Baker
USP 960 mg 60 mg 480 g 480 g 480 g
dihydrate Center Valley, USA
Monobasic
J.T Baker
sodium phosphate USP/IP 92.8 mg 5.8 mg 46.4 g 46.4 g 46.4 g
Center Valley, USA
(Monohydrate)
Dibasic sodium
J.T Baker
phosphate USP 19.2 mg 1.2 mg 9.6 g 9.6 g 9.6 g
Center Valley, USA
(Anhydrous)
J.T Baker
Polysorbate 20 USP/IP 6.4 mg 0.4 mg 3.2 g 3.2 g 3.2 g
Center Valley, USA
Water for IP/EP/US Hetero Biopharma q.s. to q. s. to 1
q. s. to 8 L q. s. to 8 L q. s. to 8 L
Injection (WFI) P/BP Limited 16 mL mL
(Note: The concentrations of excipients α,α-Trehalose dihydrate and Polysorbate 20 are calculated from per mL concentrations
at the formulated drug substance (FDS) stage. “*” indicates theoretical calculations; USP: united states pharmacopoeia)
All these excipients used for DP formulation are of multi-compendial grade, highly pure and
low in endotoxin (HPLE), and suitable for parenteral use.
Details of the specifications along with the respective test procedures are outlined in the Table
below. The specifications, in-house and manufacturer certificates of analyses (CoAs) are based
on USP.
Table 2: List of the test methods and respective specifications for the Hetero bevacizumab DP excipients
Drug product Reference
Test method Specification
excipient
White powder that readily absorbs
Description USP
moisture
Freely soluble in water and
Solubility USP
insoluble in ethanol
Identification test for
Should comply with test of sodium USP
sodium
Identification test for Should comply with test of
USP
phosphate phosphate
Insoluble substances NMT 20 mg (NMT 0.4%) USP
Sodium
phosphate Chloride NMT 0.06% USP
dibasic Sulphate NMT 0.2% USP
anhydrous
In-house Spec Arsenic (Method I) NMT 16 ppm USP
No: RS014 Loss of drying NMT 5.0% USP
98.0% to 100.5% calculated on the
Assay USP
dried basis
Bioburden USP
Total aerobic microbial
Not more than 1000 CFU/g
count (TAMC)
Total combined yeasts
and molds count Not more than 100 CU/g
(TYMC)
IP: A white powder or colorless
IP
crystals
Description
USP: Colorless crystals or
USP
crystalline powder
IP: Very soluble in water, very
IP
slightly soluble in ethanol
Solubility
USP: Freely soluble in water and
Monobasic USP
practically insoluble in ethanol
Sodium Identification test for
Phosphate Should comply with test of sodium IP & USP
sodium
(Monosodium Identification test for Should comply with test of
Phosphate IP & USP
phosphate phosphate
Monohydrate)
pH 4.1 to 4.5 IP & USP
In-house Spec
No: RS021 IP: The weight of the residue is not
IP
Insoluble substances more than 0.2 percent
USP: NMT 20 mg (0.2%) USP
Not more than 140 ppm IP
Chloride
NMT 0.014% USP
Aluminium, calcium IP: The sample solution does not
IP
and related elements become turbid when rendered

excipient
slightly alkaline to litmus paper
with 6M ammonium hydroxide
USP: The sample solution does not
become turbid when rendered
USP
slightly alkaline to litmus paper
with 6N ammonium hydroxide
IP: Not more than 8 ppm IP
Arsenic (Method I)
USP: NMT 8 ppm USP
Water (Method I) 10.0 % to 15.0 % USP & IP
Sulphate NMT 0.15 % IP
Heavy metals Not more than 20 ppm IP
Sulphate NMT 0.15% USP
IP: NLT 98.0 % and NMT 103.0
IP
% calculated on anhydrous basis
Assay
USP: 98.0 % - 103.0 % on
USP
anhydrous basis
Bioburden
TAMC Not more than 1000 CFU/g USP
TYMC Not more than 100 CU/g USP
IP: A clear or slightly opalescent,
oily, yellowish or brownish yellow IP
Description liquid
USP: Lemon to amber liquid
USP
having a faint characteristic odour
IP: Miscible with water, with
ethanol, with ethyl acetate and
with methanol. Practically IP
insoluble in fixed oils and in liquid
Solubility paraffin
USP: Soluble in water soluble in
ethanol, soluble I ethyl acetate,
USP
soluble in methanol and soluble in
mineral oils
IP & USP: Should comply with
Identification by IR IP & USP
test for identification
Poly sorbate 20 Identification B IP: Blue color is produced IP
In-house Spec Should comply with test for
Identification B USP
No: RS050 composition of fatty acids
Acid value NMT 2.0 IP & USP
Hydroxyl value 96 - 108 IP & USP
Saponification value 40 to 50 IP & USP
Water NMT 3.0 % IP & USP
pH 5.0 to 7.0 IP
Iodine value NMT 5.0 IP
Heavy metals (Method
10 ppm IP
B)
NMT 2.0 mL of 0.01 M ceric
Reducing impurities IP
ammonium sulphate is required
Sulphated ash NMT 0.2 % IP
Residue of ignition NMT 0.25 % USP
Ethylene oxide NMT 1 ppm USP

excipient
Dioxane NMT 10 ppm USP
Peroxide value NMT 5.0 USP
Assay (Composition of fatty acids)
Methyl caprylate NMT 7.0 %
Methyl Caprate NMT 5.0%
Methyl laurate NMT 48.0%
Methyl myristate NMT 15.0 % USP
Methyl palmitate NMT 7.0 %
Methyl stearate NMT 3.0 %
Methyl oleate NMT 12.0 %
Methyl linoleate NMT 3.0 %
Bioburden USP
TAMC Not more than 1000 CFU/g
TYMC Not more than 100 CFU/g
White, odourless, non-hygroscopic
Description USP
crystalline powder
Soluble in water, solubility
increases with temperature.
Solubility USP
Practically insoluble in dehydrated
alcohol
Should comply with the test for
Identification A (IR) USP
identification by IR
A violet color develops at interface
Identification B USP
between the two solutions
Identification C A brown color does not develop USP
Residue on Ignition NMT 0.1 % USP
Should comply with the test for
Related substances USP
related substances
α, α Trehalose Color and clarity of the The absorbance difference is NMT
USP
Dihydrate solution 0.100
In-house Spec Optical rotation +197o to +201⁰ at 20° USP
No: RS050 pH 4.5 to 6.5 USP
Water determination
9.0 % to 11.0 % USP
(Method I)
Chloride NMT .0.125 USP
Sulphate NMT 0.0200 % USP
Nitrogen content
NMT 0.005% USP
(Method I)
Soluble starch No blue color develops USP
97.0% to 120% on the anhydrous
Assay USP
basis
Bioburden
USP
TAMC Not more than 1000 CFU/g
TYMC Not more than 100 CFU/g
Water for Description / A clear, colorless and odourless
IP and Ph. Eur.
injection Appearance liquid.
(In-house Spec pH Between 5.0 and 7.0 IH
No: RS003) Nitrates Not more than 0.2 ppm IP and Ph. Eur.

excipient
The solution should not be red in
Acidity or Alkalinity colour or The solution should not IP
be blue in colour
Total Organic Carbon Not more than 500 ppb IP, Ph. Eur. and USP
Not more than 1.3 μS/cm at 25±2
Conductivity IP, Ph. Eur. and USP
°C
Total Aerobic Microbial Not more than 10 CFU per 100
IP and USP
Count mL
Bacterial endotoxins
Not more than 0.25 EU per mL IP, Ph. Eur. and USP
test
(IP: Indian Pharmacopoeia, Ph. Eur.: Pharmacopoeia European)
List of Enclosures:
1. QC specifications (In-House; Nos. RS051, RS021, RS050, RS014, RS003) for excipients
used for manufacturing of Hetero bevacizumab DP.
IMASTER COPY I ~ HETERO
-~ Biopharma
RAW MATERIAL SPECIFICATI ON

Title: WATER FOR INJECTION
Material Code 3002128 Reference IH/USP/Ph. Eur. /IP

RM Specification Standard Test Procedure
Supersedes Effective Date Page No.
No. No.
RS003-03 RP003t RS003-02 2 8 FEB 2019 1 of 1
S. No. TEST SPECIFICATION REFERENCES
A clear, colorless and odourless

1. Description I Appearance IP and Ph. Eur.
liquid.
2. pH Between 5.0 and 7.0 IH
3. Nitrates Not morn than 0.2 ppm IP and Ph. Eur.

The solution should not be red in
4. Acidity or Alkalinity colour or The solution should not be IP
blue in colour
IP, Ph. Eur.
5. Total Organic Carbon Not more than 500 ppb
and USP
IP, Ph. Eur.
6. Conductivity Not more than 1.3 µSiem at 25±2 °C
and USP
Total Aerobic Microbial
7. Not more than 10 CFU per 100 ml IP and USP
Count
IP, Ph. Eur.
8. Bacterial endotoxins test Not more than 0.25 EU per ml
and USP
t "Follow the current revision of STP"
Sample Quantity:
Chemical analysis - 100 ml approximately
TOC - 40 ml (TOC vial)
Microbial examination - 250 ml approximately
BET - 10 ml (BET vial)
PREPARED BY REVIEWED BY APPROVED BY

Quality Control Head - QC Quality Assurance Head - QA
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RAW MATERIAL SPECIFICATION

Title: SODIUM PHOSPHATE DIBASIC ANHYDROUS
Material Code: 1004009 Reference USP

RM Specification Standard Test
No. Procedure No.
RS014-05 RP014t RS014-04 2 9 JAN ZOZO 1of2
White powder that readily absorbs

1. Description USP
moisture
Freely soluble in water, insoluble in

2. Solubility USP
Ethanol

3. Should comply with the test for Sodium USP
Sodium
Identification test for Should comply with the test for

4. USP
Phosphate Phosphate
5. Insoluble substances NMT 20 mg (NMT 0.4 %) USP
6. Chloride NMT 0.06 % USP
7. Sulfate NMT 0.2 % USP
8. Arsenic (Method I) NMT 16 ppm USP
9. Loss on drying NMT 5.0 % USP
10. Assay 98.0 % to 100.5 % on the dried basis USP
11 . Bioburden
TAMC Not more than 1000 CFU I g USP
TYMC Not more than 100 CFU I g USP

t "follow current version of STP".

Quality Control Head -QC Quality Assurance Head-QA
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I MASTER co~ ~Biopharma

Title: SODIUM PHOSPHATE DIBASIC ANHYDROUS

No. Procedure No.
Reduced testing parameters

S. No. Name of the test
1. Description
2. Identification test for Sodium
3. Identification test for Phosphate

4. LOO
5. Assay
6. Bioburden
Re-testing parameters
1. Description
4. LOO
5. Assay

Quality Control Head -QC Quality Assurance Head -QA
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IMASTER COPY I ~H ETERO
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Title: MONOBASIC SODIUM PHOSPHATE (MONOSODIUM PHOSPHATE MONOHYDRATE)
Material Code: 1004008 Reference IP & USP

No. Procedure No.
RS021-07 RP021t RS021-06 2 9 JAN ZOZO Page 1of3
A White powder or colourless crystals IP

1. Description
Colorless crystals or white crystalline
USP
powder
Very soluble in water, very slightly

IP
soluble in Ethanol
2. Solubility
Freely soluble in water and practically
USP
insoluble in Ethanol
3. Should comply with test for Sodium IP & USP
Sodium
4. Should comply with test for Phosphate IP & USP
Phosphate
5. pH 4.1to4.5 IP & USP
The weight of the residue is not more
IP
6. Insoluble substances than 0.2 per cent
NMT 20 mg (0.2 % ) USP

7. Chloride
NMT 0.014 % USP
The sample solution does not become
turbid when rendered slightly alkaline to
IP
litmus paper with 6 M Ammonium
Aluminum, Calcium and hydroxide
8.
related elements The sample solution does not become
turbid when rendered slightly alkaline to
USP
litmus paper with 6 N Ammonium
hydroxide

Quality Control Head - QC Quality Assurance Head-QA
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IMASTER COPY I ~ HETERO
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No. Procedure No.
RS021-07 RP021t RS021-06 2 9 JA...t 1mll Page 2of3

9. Arsenic (Method I)
NMT 8 ppm USP
10. Water (Method I) 10.0 % to 15.0 % USP & IP
11 . Sulphates NMT 0.15 % IP
12. Heavy metals Not more than 20 ppm IP
NLT 98.0 % and NMT103.0 % calculated

IP
on anhydrous basis
14. Assay
98.0 % - 103.0 % on anhydrous basis USP
Bioburden
15. TAMC Not more than 1000 CFU I g USP

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No. Procedure No.
RS021-07 RP021t RS021-06 2 9 JAN ZOZO Page 3 of 3
1. Description
4. Water (Method I)
5. Assay
6. Bioburden
5. No. Name of the test
1. Description
4. Water (Method I)
5. Assay

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Title: POLYSORBATE 20

RM. Standard Test
Specification No. Procedure No.
RS050-05 RP050t RS050-04 7 ~ JAN 20ZO 1of4
A clear or slightly opalescent, oily,

IP
yellowish or brownish yellow liquid
1. Description
Lemon to amber liquid having a
USP
faint, characteristic odor
Miscible with water, with Ethanol,

with Ethyl acetate and with
IP
Methanol. Practically insoluble in
fixed oils and in Liquid Paraffin
2. Solubility
Soluble in water, soluble in Ethanol,
soluble in Ethyl acetate, soluble in
USP
Methanol and soluble in Dioxane
and insoluble in Mineral oil
Should comply with test for

3. Identification by IR IP & USP
identification by IR
4. Identification B Blue colour is produced IP
Should comply with test for

5. Identification B USP
composition of Fatty acids
6. Acid value NMT 2.0 IP & USP
7. Hydroxyl value 96 - 108 IP & USP

Quality
Quality Control Head -QC Head-QA
Assurance
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~H ETERO
IMASTER COPY I ~Biopharma

RM. Standard Test
RS050-05 RP050t RS050-04 Z9 JAN ZOZO 2 of 4
8. Saponification value 40 to 50 IP & USP
9. Water NMT 3.0 % IP & USP
10. pH 5.0 to 7.0 IP
11 . Iodine value NMT 5.0 IP
12. Heavy metals (Method 8) 10 ppm IP
NMT 2.0 ml of 0.01 M eerie

13. Reducing impurities IP
ammonium sulphate is required
14. Sulphated ash NMT 0.2 % IP
15. Residue on ignition NMT 0.25 % USP
Ethylene oxide NMT 1 ppm

16. USP
Dioxane NMT 10 ppm
17. Peroxide value NMT 5.0 USP
18. Assay (Composition of Fatty acids)

Quality
Assurance
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RM. Standard Test
RS050-05 RP050t RS050-04 Z9 JAN ZUZU 3 of 4
Methyl caprylate NMT 10.0 %
Methyl caprate NMT 10.0 %
Methyl laurate 40.0-60.0 %
Methyl myristate 14.0- 25.0 %
Methyl palmitate 7.0-15.0 % USP
Methyl stearate NMT 11.0 %
Methyl oleate NMT 11.0 %
Methyl linoleate NMT 3.0 %
Methyl caproate NMT 1.0 %
Bioburden
19. TAMC Not more than 1000 CFU I ml USP
TYMC Not more than 100 CFU I ml USP
t "Follow current version of STP".
,
Quality
Assurance
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RM. Standard Test
RS050-05 RP050t RS050-04 29 JAN 2020 4 of 4

1. Description
2. Identification by IR
3. Identification B
4. Identification B
5. Water
6. Peroxide value
8. Bioburden
1. Description
2. Identification by IR
3. Identification B
4. Identification B
5. Water

Quality
Assurance
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CHANGE HISTORY SHEET
Department : Quality Control I Document No.: RSOS0-05
Document Title: POLYSORBATE 20
Version Supersedes S. No. Change Made
New Specification Nil Nil Nil
RS050-01 RS050-00 01 For the changes refer CRN No.:

QCC034/15 Initiated Date: 27-06-
2015.

QCC085/15 and QCC010/16.
RS050-03 RS050-02 01 For the changes refer CRN No. :

QCC035/16.
RS050-04 RS050-03 01 For the changes refer CRN No. :

MBC017/17.

QCC112/19.

User Department Head of The Department Quality Assurance
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Title: a,a-TREHALOSE DIHYDRATE

RM. Standard Test
S.No TEST SPECIFICATION REFERENCES
White, odorless, non hygroscopic

1. Description USP
crystalline powder
Soluble in water, solubility increase with

2. Solubility temperature. Practically insoluble in USP
dehydrated Alcohol
Identification by Infrared Should comply with the test for

3. USP
absorption Identification by IR
A violet color develops at the interface

4. Identification B USP
between the two solutions
5. Identification C A brown color does not develops USP
6. Residue on Ignition NMT 0.1 % USP
Should comply with the test for related

7. Related substances USP
substances
Color and clarity of the
8. The absorbance difference is NMT 0.100 USP
solution
9. Optical Rotation + 197 ° to + 201 ° at 20 ° USP
10. pH 4.5 to 6.5 USP

.
Water Determination
11 . 9.0 % to 11.0 % USP
(Method I)
12. Chloride NMT 0.0125 % USP

Quality Control Head-QC Quality Assurance Head -QA
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RM. Standard Test
RS051-05 RP051t RS051-04 l 9 JAN 2020 2 of3
S.No TEST SPECIFICATION REFERENCES
Nitrogen Content
14. NMT 0.005 % USP
(Method I)
15. Soluble Starch No blue color develops USP
97.0 % to 102.0 % on the anhydrous

16. Assay USP
basis
Bioburden
17. TAMC Not more than 100 CFU I g USP
1. Description
2. Identification by Infrared absorption
3. Identification B
4. Identification C
5. Water Determination (Method I)
6. Assay
7. Bioburden

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RM. Standard Test
1. Description
2. Identification by Infrared absorption
3. Identification B
4. Identification C
5. Water Determination (Method I)
6. Assay

Quality Control Head -QC Quality Assurance Head -QA
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3.2.P.4.1 Excipients

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Bevacizumab (400mg/16mL, Single use vial)

3.2.P DRUG PRODUCT (BEVACIZUMAB, HETERO BIOPHARMA LIMITED)

Drug product Reference

Drug product Reference

Drug product Reference

RAW MATERIAL SPECIFICATI ON

Material Code 3002128 Reference IH/USP/Ph. Eur. /IP

S. No. TEST SPECIFICATION REFERENCES

A clear, colorless and odourless

2. pH Between 5.0 and 7.0 IH

3. Nitrates Not morn than 0.2 ppm IP and Ph. Eur.

t "Follow the current revision of STP"

PREPARED BY REVIEWED BY APPROVED BY

RAW MATERIAL SPECIFICATION

Material Code: 1004009 Reference USP

S. No. TEST SPECIFICATION REFERENCES

White powder that readily absorbs

Freely soluble in water, insoluble in

Identification test for

Identification test for Should comply with the test for

5. Insoluble substances NMT 20 mg (NMT 0.4 %) USP

6. Chloride NMT 0.06 % USP

7. Sulfate NMT 0.2 % USP

8. Arsenic (Method I) NMT 16 ppm USP

9. Loss on drying NMT 5.0 % USP

10. Assay 98.0 % to 100.5 % on the dried basis USP

TAMC Not more than 1000 CFU I g USP

TYMC Not more than 100 CFU I g USP

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RAW MATERIAL SPECIFICATION

Material Code: 1004009 Reference USP

Reduced testing parameters

2. Identification test for Sodium

3. Identification test for Phosphate

2. Identification test for Sodium

3. Identification test for Phosphate

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Material Code: 1004008 Reference IP & USP

S. No. TEST SPECIFICATION REFERENCES

A White powder or colourless crystals IP

Very soluble in water, very slightly

Not more than 140 ppm IP

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Material Code: 1004008 Reference IP & USP

S. No. TEST SPECIFICATION REFERENCES

Not more than 8 ppm IP

10. Water (Method I) 10.0 % to 15.0 % USP & IP

11 . Sulphates NMT 0.15 % IP

12. Heavy metals Not more than 20 ppm IP

13. Sulfate NMT 0.15 % USP

NLT 98.0 % and NMT103.0 % calculated

15. TAMC Not more than 1000 CFU I g USP

TYMC Not more than 100 CFU I g USP

t "follow current version of STP".

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Material Code: 1004008 Reference IP & USP

Reduced testing parameters

S. No. Name of the test

2. Identification test for Sodium

3. Identification test for Phosphate

5. No. Name of the test

2. Identification test for Sodium

3. Identification test for Phosphate

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