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Chemical name: (+/-)-6-chloro-alpha-methylcarbazole-2-acetic acid
Molecular formula: C15H12ClNO2
Molecular weight: 273.71
CAS: 53716-49-7
Structural formula:

A: In-house specification Combin ation of specification in USP and EP)
Appearance: White or off-white crystalline powder
Loss on drying (USP): ≤0.5%
Residue on ignition (USP): ≤0.1%
Assay (calculated on dried substance) (USP): 98.0~102.0%
Carbazole(USP): ≤0.5%
Ketal(USP): ≤0.5%
6-chloro- biacetylcarbazole (USP): ≤0.5%
Any individual unspecified impurity(USP): ≤0.10%
Total impurities(USP): ≤1.0%
Total aerobic microbial count: ≤100cfu/g
Total yeast and mold count: ≤50cfu/g
Bacterial endotoxins: <0.25EU/mg
B: In accordance with EP
Appearance: White or off-white crystalline powder
Loss on drying: ≤0.5%
Sulfated ash: ≤0.1%
Any individual unspecified impurity: ≤0.20%
Total impurities: ≤0.5%
Heavy metal: ≤20ppm
Assay: 98.5~101.5%
C: Specification for Veterinary drug
Characters: White or off-white crystalline powder. Freely soluble in acetone and methanol, slightly soluble in isopropyl alcohol, practically insoluble in water.
Loss on drying: ≤0.5%
Residue on ignition: ≤0.1%
Heavy metal: ≤20ppm
Carbazole: ≤0.5%
Ketal: ≤0.5%
6-chloro- biacetylcarbazole: ≤0.5%
Any individual unspecified impurity: ≤0.10%
Total impurities: ≤1.0%
Assay: 98.0~102.0%
Packing size: 25Kg/drum
Indications: It has strong anti-inflammatory, analgesic and antipyretic effects, used for rheumatoid arthritis, osteoarthritis, acute gout, tendonitis, bursitis, soft tissue off injury or acute pain after surgical operation or a wound.

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