COMPOSITION OF DRUG

FORMULATION

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 ANNEXURE – 06
Composition (active & Excipients) including statement of the quantitative composition, giving the weight or measure for each substance
used in the manufacture of the dosage.
COMPOSITION OF THE DRUG:
AZITHROMYCIN 250MG TABLETS
      PER TABLET FOR BATCH OF
100000 TABLETS  
Sr# MATERIAL Pharmacopia QUANTIT UNIT QUANTIT UNIT FUNCTION
l Ref. Y Y
Core Tablet
1 Azithromycin Dihydrate* USP 262.05 Mg 26.205 Kg API
2 Microcrystalline Cellulose BP 129.73 Mg 12.973 Kg Diluent
3 Primojel USP 18.00 Mg 1.800 Kg Disintegrant
4 Sodium Lauryl Sulfate USP 13.11 Mg 1.311 Kg Disintegrant
5 Starch BP 54.00 Mg 5.400 Kg Diluent
6 Silicon Dioxide BP 5.00 Mg 0.500 Kg Lubricant
7 Magnesium Stearate BP 13.11 Mg 1.311 Kg Lubricant
8 DI Water BP 0.15 mL 15 Lit. Solvent
Film Coating
1 Colorcoat FC4S In-House 5.00 Mg 0.5 Kg Film Coat
2 Isopropyl Alcohol BP 0.90 mL 90 Lit. Solvent
               
Weight per Tablet (Core) =   495.00 Mg Batch Size: 49.500 Kg
  Weight per Tablet (Coated) =   500.00 Mg    
               
Formulation Reference:            
  https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf  
  https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050710s44-050711s41-050784s28lbl.pdf  
* No Overage            

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 ANNEXURE – 07
COMPLETE MANUFACTURING OPERATIONS

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 ANNEXURE – 16

Outline of the method of manufacture, complete manufacturing operations from step A to Z in

addition to the following:
1. Master formula
2. Manufacturing operations.
3. Critical steps identified which may change the results.
4. In- process Quality control.
5. Validation of equipment & manufacturing methods.

METHOD OF MANUFACTURING:
AZITHROMYCIN AS DIHYDRATE 250mg TABLETS

Sifting & mixing:

Sieve the Azithromycin Dihydrate & half part of Starch and Microcrystalline Cellulose through
mesh # 20 one by one and collect the material in 50 kg plastic drum lined with polythene bag and
transfer the material with S.S. scope into the mixer one by one. Mix at slow speed for 25- 30 min,
and note the time with the help of stopwatch.

Preparation of granulation solution;

Into the S.S. container of approx.25 l takes DI Water and adds remaining half part of Starch and
Microcrystalline Cellulose. Stir with the spatula until a homogenous paste is prepared.

Wet granulation:
Add granulation solution prepared above along with binder solution in the mixer and mix for 15-20
minutes, at slow speed of mixing. Add Primojel & Sodium Lauryl Sulfate one by one and mix for 5
minutes. Scrap the sticking material and then close the lid of mixer and again mix for about 5-6
minutes. Sieve the wet material through rotary wet granulator and transfer wet granules in trays.

Drying:
Wet granules prepared above are transferred in the trays and placed in the tray dryer, dry for 5-6
hrs at 50 - 70ºC. in order to obtain the moisture content of < 2 %. Transfer the dry granules into the
hopper of oscillating granulator fitted with mesh # 20 and crush these granules and collect them in
a plastic drum through polybags attached with the granulator outlet and fill the granules in
containers.

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Final mix:
Finally sieve Silicon Dioxide & Magnesium Stearate through mesh # 20 and collect them in
polybag and then add into the mixer already contain the crush granules. Mix the above material in
the mixer for about 10 – 15 minutes.

Collect the obtained granules in plastic drum lined with the polythene bag. Label the container with
product label. Bring all the containers to the specified area for weighing and measure the net
weight of the granules.

Storage & compression:

Store the granules at the room temperature and send the sample to the quality control for analysis.
After the approval of quality control compress the tablets on ZP-17 at the weight given by the
quality control on controlled humidity and temperature conditions. Send the sample to the quality
control for analysis.

Film Coating:
Prepare coating solution by mixing Color Coat FC4S in 5 Liters of Alcohol. Mix for 5 minutes.

After the approval of quality control, coat the core tablets on controlled humidity and temperature
conditions. After coating send sample of coated tablets to Quality Control Department for
Analysis.

Blistering & Packing:

After the approval of quality control, start blistering and packing as per SOP under controlled
humidity and temperature conditions.

Note:- During Mixing, Compression, Film Coating, Blistering and Packing, follow QA procedures
for Sampling, Inprocess Checking, Environmental Parameters Monitoring etc on pre-defined
intervals.

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 ANNEXURE – 10
FINISHED PRODUCT SPECIFICATION
METHOD OF ANALYSIS

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 ANNEXURE – 10
Full description of the specifications and analytical methods necessary to assure the
identity, strength, quality, purity and homogenicity throughout the shelf life of the drug
product including following.
1. Validation of Analytical Method
2. Stability Reports

FINISHED PRODUCT SPECIFICATION

AZITHROMYCIN 250mg TABLETS

COMPOSITION:
Each Film Tablet Contains:
Azithromycin as Dihydrate (USP)……..…….250mg
(Product complies USP Specs)

No Parameter Specification
1 White to Off White Color Oblonged Film Coated
Physical Description
Tablet.
2 Identification Must be positive for Azithromycin.
3 Average weight / Tablet 500 mg ± 5%

4 Dissolution NLT 80% (Q) of the labeled amount of

Azithromycin is dissolved in 30 min.
5 NLT 90.0% and 110.0% of the labeled amount of
Assay
Azithromycin.

* As the Method of Analysis of Finished Product is taken from Official Pharmacopeia, hence Method Validation
Studies not required.

** For Stability Studies Data, kindly referrer to commitment present in the dossier.

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 FINISHED PRODUCT
METHOD OF ANALYSIS
AZITHROMYCIN 250mg TABLETS

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 STABILITY STUDIES
Accelerated Stability Studies Data will be submitted after import of Azithromycin
Dihydrate and after preparation of Trial / Pilot Batches and completion of Accelerated
Stability Studies.
(Refer to our undertaking on this regards).

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