Product

Sulphamethoxazole

Pharmacopoeia

BP2002

Batch No.

A-40221208006

Quantity

1000kg

Manufacture Date

AUG.06,2012

Expiry Date

JUL.2017

Test

Standards Required

Test Results

Characters

A white or almost white crystalline power

Almost white

crystalline powder

Solubility

Practically insoluble in water, freely soluble in acetone, sparingly soluble in alcohol, slightly soluble in ether. It dissolves in dilute solutions of sodium hydroxide..

Complies

Identification

(a)  Melting point

(b)  IR

(c)   TLC

(d)  Chemical test

169.0-172.0°C (2.2.14)

As per the spectrum of sulfamethoxazole CRS

As per BP2002

Give reaction of primary Aromatic Amines (2.3.1)

170.8-170.9°C

Complies

Complies

Complies

Test

Appearance of solution

Acidity

Related substances by TLC

Heavy Metals

Loss on drying

Sulfated ash

≤Y₅ ;≤BY₅;≤GY₅(2.2.2. method II)

Not more than 0.3ml of 0.1M NaOH

≤0.5% (2.2.27)

≤20ppm (2.4..8)

≤0.5% (2.2.32)

≤0.1% (2.4.14)

Complies

0.24ml

<0.5%

<20ppm

0.1%

0.04%

Assay (on dried basis)

99.0-101.0% (2.5.8)

99.9%

Results: The commodity meets the standard of BP2002