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This document is a certificate of analysis for a batch of Butamirate Citrate produced by FARMAK, A.S. The batch passed all tests for identity, purity, and quality. Key details include:
- The batch number is 1009568424 with a manufacturing date of 01 SEP 2018 and expiry date of 30 SEP 2023.
- All test results, including for assay, appearance, solubility, identification, melting range, pH, impurities and loss on drying were within specifications.
This document is a certificate of analysis for a batch of Butamirate Citrate produced by FARMAK, A.S. The batch passed all tests for identity, purity, and quality. Key details include:
- The batch number is 1009568424 with a manufacturing date of 01 SEP 2018 and expiry date of 30 SEP 2023.
- All test results, including for assay, appearance, solubility, identification, melting range, pH, impurities and loss on drying were within specifications.
This document is a certificate of analysis for a batch of Butamirate Citrate produced by FARMAK, A.S. The batch passed all tests for identity, purity, and quality. Key details include:
- The batch number is 1009568424 with a manufacturing date of 01 SEP 2018 and expiry date of 30 SEP 2023.
- All test results, including for assay, appearance, solubility, identification, melting range, pH, impurities and loss on drying were within specifications.
Manufacturer : FARMAK, A.S. , USA Supplier : FARMAK, A.S. , USA Vendor Batch : 3213546431 Mfg. Date : 01 SEP 2018 Batch Quantity : 400 KG Containers : 40 Expiry Date : 30 SEP 2023 Batch Number : 1009568424 Test Date : 12 NOV 2019 Retest Date : 12 NOV 2020
Certificate of Analysis
Tests Specification Test Results
Working Assay Working Assay 99.56% Calculated Assay % Calculated Assay % 99.56 Appearance White to slightly yellow crystalline powder, White crystalline powder, slightly waxy, slight slightly waxy, slight amine odour. amine odor. Solubility Sparingly soluble in water, soluble in Sparingly soluble in water, soluble in ethanol ethanol(96%). (96%). Identification A. FTIR Spectrum: The infrared absorption A. FTIR Spectrum: Complies. B. UV Spectrum: spectrum of the sample must be concordant with Complies. C. Test for citrates: [Positive]. that of working standard spectrum. B. UV Spectrum: Should be identical with reference standard spectrum.C. Test for citrates: Should be positive with the test for citrates. Melting range Melting range Between 74°C and 78°C. 74.9°C Appearance of solution Not more intense than the reference solution Y6 Complies. pH Between 3.50 and 4.00 3.8 Chlorides Not more than 0.005% Less than 0.005% Heavy metals Not more than 0.001% Less than 0.001% Readily carbonizable Not more intense the reference solution BY5 Complies. substances Loss on drying Not more than 1.0% w/w 0.2% Sulphated ash Not more than 0.1% w/w 0.04%