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Paracetamol API COAs

This Certificate of Analysis confirms that the active raw material Paracetamol, batch number 00510921/22-10/012, meets all specified quality control standards. The analysis includes tests for appearance, identification, solubility, loss on drying, sulphated ash, and assay, all of which comply with the specifications. The product is released for use, with a manufacturing date of September 2022 and an expiration date of September 2027.

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329 views1 page

Paracetamol API COAs

This Certificate of Analysis confirms that the active raw material Paracetamol, batch number 00510921/22-10/012, meets all specified quality control standards. The analysis includes tests for appearance, identification, solubility, loss on drying, sulphated ash, and assay, all of which comply with the specifications. The product is released for use, with a manufacturing date of September 2022 and an expiration date of September 2027.

Uploaded by

naeem186
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

QUALITY CONTROL DEPARTMENT

CERTIFICATE OF ANALYSIS
ACTIVE RAW MATERIAL
WBPC/QC/DOC/17
COA No :RMA-001

Item/Material Name: Paracetamol


Batch No: 00510921/22-10/012 Quantity: 60.0Kg Sampling Date: 30-01-2023
Mfg. Date: 09-2022 Exp. Date: 09-2027 Re-test Date: 29-01-2024
Q.C. No: QC-RMA-002 Report Date: 02-11-2023 Reference: B.P Specs
API Manufacturer: Pharmagen Limited
Sr.No Tests Specifications Results
1. Appearance White or almost white crystalline powder Complies
2. Identification Complies
1. 168-172◦C
1. Melting point
2. FTIR Spectrum must corresponds
2. FTIR

3. Sparingly soluble in water, freely soluble in Complies


Solubility
alcohol, Very slightly soluble in methylene chloride
4. Loss on drying NMT 0.5% 0.30%
5. Sulphated Ash NMT 0.1%w/w 0.05%
6. Assay 99.0-101.0% (Dried basis) 99.60%

Remarks: The product complies with given specifications hence released.

___________ ______________________________
ANALYST QUALITY CONTROL MANAGER

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