Paracetamol DC90 (Acetaminophen, CAS No. 103-90-2)

Test

Specification

Appearance

White granules

Identification

   Infrared Absorption

Sample and standard spectra are qualitatively identical.

Assay

87.5-92.5%

Loss on drying

0.50-2.50%

Bulk density

0.30-0.70g/cm3

Sieve Analysis:

   Retained on USS 20

NMT 10%

   Retained on USS 30

Report

   Retained on USS 40

Report

   Accumulated on USS 30 40 50

Report

   Accumulated on USS 80

NLT 60%

Pan

NMT 40%

Related Substances:

Impurity J: 4-chloroacetanilide ≤ 10ppm

Impurity K: 4-aminophenol ≤ 50ppm

Impurity F: 4-nitrophenol ≤ 0.05%

Total content of Ethyl Hydroxyl Benzoate

and Propyl Hydroxyl Benzoate: ≤ 0.5%

Other impurities: ≤ 0.05%

Total of other impurity: ≤ 0.15%

Microbial Limits:

   Mold

NMT 100 CFU/g

   Salmonella

None

   Escherichia coli

None

Paracetamol EP5 (Acetaminophen, CAS No. 103-90-2)

Test

Specification

Characteristics

White, crystalline powder. Sparingly soluble in water, freely

soluble in alcohol, very slightly soluble in methylene chloride.

Identification

   A: Melting point

168-1720C

   C: IR absorption

Complies

   B,D,E: Chemical identification

Complies

Related Substances:

Impurity J: 4-chloroacetanilide ≤ 10ppm

Impurity K: 4-aminophenol ≤ 50ppm

Impurity F: 4-nitrophenol ≤ 0.05%

Any other impurity: ≤ 0.05%

Total of other impurity: ≤ 0.1%

Sulphates

NMT 0.1%

Heavy metals

NMT 20ppm

Loss on drying

NMT 0.5%

Residual solvent

Residual content of acetic acid is limited by the test of loss on

drying NMT 0.5%

Assay

99.0-101.0% (dried substance)

Paracetamol BP2007 (Acetaminophen, CAS No. 103-90-2)

Test

Specification

Characteristics

A white crystalline powder, odourless, slight bitterness

Solubility

Complies

Identification

Positive

Melting point

168-1720C

Heavy metals

NMT 20ppm

P-aminophenol

NMT 0.005%

Related Substances

Complies

Loss on drying

NMT 0.5%

Sulphated ash

NMT 0.1%

Assay

99.0-101.0%