Product Name

Sulfamethoxazole

Pharmacopoeial standard

BP2000

Batch iden code

20200116

Gross weight

27.5KGD/DRUM

Batch size

400KGS

Net weight

25KGS/DRUM

MFG. Date

15 Jan. 2020

Exp. Date

Dec. 2024

Analysis Date

15 Jan. 2020

Release Date 

15 Jan. 2020

ITEMS

SPECIFICATIONS

RESULTS

Characters

A white or almost white crystalline powder

Up to standard

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.

Up to standard

Identification

a. Melting point

169.0℃~172.0℃

169.5℃~170.0℃

b. IR

As per the spectrum of sulpamethoxazole CRS

Up to standard

c. TLC

As per BP

Up to standard

d. Chemical test

Give reaction of primary aromatic aminos

Up to standard

Appearance of solution

≤Y₅；≤BY₅；≤GY₅

Up to standard

Acidity

Not more than 0.3ml of 0.1M NaOH

Up to standard

Related substances by TLC

≤0.5%

＜0.5%

Heavy metals

≤20ppm

＜20ppm

Loss on drying

≤0.5%

0.2%

Sulfated ash

≤0.1%

0.02%

Assay（on dry basis）

99.0%~ 101.0%

99.8%

Remarks  

The commodity meets the standard of BP2000