This document provides documentation of the raw material analysis conducted for croscarmellose sodium submitted by Jaya Prakash V. It introduces the importance of documentation in the pharmaceutical industry and discusses good documentation practices. The document then analyzes the raw material croscarmellose sodium against specifications in the British Pharmacopoeia, including tests for identification, microbial limits, pH, loss on drying, heavy metals, and settling volume. The conclusion indicates that croscarmellose sodium passed all acceptance tests for the analyzed parameters.

1. DOCUMENTATION OF RAW
MATERIAL ANALYSIS FOR
CROSCARMELLOSE
SODIUM
SUBMITTED BY,
JAYA PRAKASH V,
218311.

2. INTRODUCTION
• Document is any written statement or proof of any activity
in pharmaceuticals. ...
• Documentation is a systematic procedure of preparation,
checking, verifying, issuing, storing and reviewing of any
documents.
• Due to the importance given to documentation in
pharma “good documentation practices” is required.
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3. • “Good documentation practice is an essential part of the
quality assurance and such, related to all aspects of GMP”
• Documentation provides Both;
• 1. Information on when, where, who, why & How to
Complete tasks
• 2. Evidence providing that the tasks have been completed as
they should be
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4. Purpose of Documentation
• Defines specifications and procedures for all materials and
methods of manufacture and control
• Ensures all personnel know what to do and when to do it
• Ensure that authorized persons have all information
necessary for release of product
• Ensures documented evidence, traceability, provide records
and for investigation
• Ensures availability of data for validation, review and
statistical analysis
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5. 5

6. Analysis of Raw material
• Before manufacturing begins, all raw materials must be tested
for purity, identity and quality.
• The extent of raw material testing is determined by the
manufacturer.
• BP provides monographs for the most commonly used raw
materials in the pharmaceutical industry.
• Physical and chemical raw material analysis
• Chromatography
• Assays
• Microbial tests
• Impurities
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7. • EXAMPLE:
• Croscarmellose sodium, or sodium CMC, is a cross-linked
polymer of carboxy methyl cellulose sodium .
• use as a superdisintegrent in pharmaceutical formulations.
• The raw material analysis for this compound is basically takes
place by using the british pharmacopeia.
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8. • Identification : Mix 1 g of it with 100 mL of methylene blue
solution , stir the mixture, and allow it to settle.
• The Croscarmellose Sodium absorbs the methylene blue and
settles as a blue, fibrous mass.
• Microbial limits :The total aerobic microbial count does not
exceed 1000 per g, the total combined molds and yeasts count
does not exceed 100 per g, and it meets the requirements of
the tests for absence of Escherichia coli.
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9. • pH :Mix 1 g of it with 100 mL of water for 5 minutes the pH
of the dispersion is between 5.0 and7.0.
• Loss on drying :Dry it at 105º for 6 hours . it loses not more
than 10.0% of its weight.
• Heavy metals: 0.001%
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10. • Settling volume :
• To 75 mL of water in a 100mL graduated cylinder add 1.5 g of
it in 0.5g portions, shaking vigorously after each addition.
• Add water to make 100 mL, shake again until all of the
powder is homogeneously distributed, and allow to stand for 4
hours.
• Note the volume of the settled mass. It is between 10.0 and
30.0 mL.
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11. CONCLUSION: Document is prepared for raw material
analysis on croscarmellose sodium
Test Acceptance Analysis P/F
Microbial limit 1000 per g 700 per g pass
Loss on drying 10% 8.5% pass
Settling
volume
10ml to 30ml 20ml pass
Content of
water
10% 9% pass
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12. THANK YOU
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