This certificate of analysis provides information about a batch of carbocisteine produced by Shandong Octagon Chemicals Limited. It summarizes the results of tests on the product's appearance, identification, pH, optical rotation, impurities, loss on drying, sulfated ash, and assay. All test results were found to meet the standards of the European Pharmacopoeia 8.0 and the batch is approved for storage and sale.

1. SHANDONG OCTAGON CHEMICALS LIMITED
CERTIFICATE OF ANALYSIS
TEL:0086-15589503653 FAX:0086-0535-6715688
Address: Rm 528, Building 2, No. 300-2, Changjiang Rd, YEDA, YanTai City, ShanDong
Province, China sales@octagonchem.com
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Product name Carbocisteine
Batch No. 20100801 Mfg. date 2020.08.10
Rep. Date 2020.08.18 Exp. date 2022.08.09
Packaging 25kg/Drum Batch Size 1859.60KG
Test Items Standards: EP8.0 Results
Appearance A white to crystalline powder conforms
Identification
A Conforms
B Conforms
Appearance of
solution
Clear and colorless Conforms
PH 2.8~3.0 2.92
Optical rotation -32.5 ~ -35.5° -33.58°
Ninhydrin-positive
substances
Should conform Conforms
Chloride NMT0.15% <0.15%
Sulphate NMT300ppm <300ppm
Heavy metals NMT10ppm <10ppm
Loss on drying NMT0.5% 0.25%
Suphated ash NMT0.3% 0.18%
Assay 98.5%~101.0% (on dried basis) 99.61%
Conclusion It meets the requirements of EP8.0 Standards
Storage Store in a well-closed container at ambient temperature
Prepared by: LI Reviewed by: WEI Released by:Zhang