Tetraciclina hcl

Product Name

Tetracycline hydrochloride

Batch No.

20130115

Spec.

25kgs/Fibre Drum

MFG.Date

29-Dec-2012

EXP. Date

29-Dec-2016

Report Date

22-Jan-2013

To be analyzed according to BP2010 results of examination

Items

Standard

Results

Characters

Appearance:Yellow,crystalline powder

Solubility:Soluble in water,slightly soluble in ethanol(96%),practically insoluble in acetone.

Pass

Pass

Identification

A,similar. B,C,Positive

Pass

pH

1.8~2.8

2.4

Specific optical rotation(dried substance)

-240°~-255°

-245°

Related Substances

A:4-epitetracycline not more than 3.0%

1.3%

C:Anhydrotetracycline not more than 0.5%

0.11%

D:4-epianhydrotetracycline not more than 0.5%

0.02%

B:2-acetyl-2-decarbamoyltetracycline not more than 1.5%

0.88%

Heavy metals

Complies with limit test(50ppm)

Pass

Loss on drying

Not more than 2.0%

0.46%

Sulphated ash

Not more than 0.5%

0.08%

Assay(dried substance)

95.0% to 102.0%

96.0%

Residual solvents

1-      butanol

2-      Acetone

Not more than 5000ppm

Not more than 5000ppm

3675ppm

8ppm

Conclusion: It complies with EP2010.