Hydroxychloroquine sulphate

  • ₹ 5,09,80,800
  • 1 ton
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Product Details

  • ID
    CH-JKYkYhk
  • CAS Number
  • Sub Category
    Active Pharmaceutical Ingredients (API)
  • Published On
    10-Jun-2020
  • Purity Percentage
    99.9
  • Country
    India
  • City
  • Certified By
    FDA

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COA or MSDS Details

Tests

Method

Specifications

Results

Description

Visual

White or practically white crystalline powder

Almost white crystalline powder

Identification by UV

USP <197U>

Meet the requirements

Conforms

Identification by IR

USP <197K>

Sample spectrum conforms to that of standard spectrum

Conforms

Identification

USP <191>

Meet the requirements for sulfate

Conforms

Loss on drying

USP <731> at 105 oC for 2 hrs

NMT 2.0%

0.2%

Ordinary impurities by TLC

USP <466>

Meets the requirements.

Conforms

Assay by UV

USP method

NLT 98.0% and NMT 102.0% (on the dried basis)

100.3%

Residual solvents

HSGC House Method

Methanol: NMT 0.6%

Methyl isobutyl Ketone: NMT 0.45%

Isopropanol : NMT 0.5%

Di methyl ether: NMT 500 ppm

0.4%

0.08%

 

ND

30 ppm

Particle Size

Laser diffraction

D (v, 0.1): Report value

D (v, 0.5): Report value

D (v, 0.9): Report value

22 mm

136 mm

284 mm

Remarks: The batch complies with the above specifications

 

Manufacture APIs in compliance with CGMP and strictly adhere to the manufacturing process and methods described in our DMFs by maintaining safety / environmental laws and guidelines in all operations

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