pharmaceutical Leuprorelin Acetate-peptide

Test

Specification

Result

Test method

Reference No.

Appearance

(EP.curr.ed)

Hygroscopic, White or

 off-white powder

 Hygroscopic, White or

 off-white powder

PT/QC/LP/01-1

Solubility

Very soluble in water, 1% acetic acid

.

Very soluble in water, 1% acetic acid

PT/QC/LP/01-2

HPLC

(EP.curr.ed)

The principal peak in the chromatogram obtained with the test solution is similar in retention time to principal peak in the chromatogram obtained with the reference solution.

Complies

PT/QC/LP/01-3

IR spectrophotometry

(EP.curr.ed)

The spectrum obtained is similat to the reference spectrum.

Complies

PT/QC/LP/01-4

Amino acid analysis

(EP.curr.ed)

Amino acid    limits

No more than the traces

of the other amino acids are present.

1.02

1.01

1.96

1.03

0.95

1.05

present

Complies

PT/QC/LP/01-5

Sulphated Ash

 (EP.curr.ed)

NMT 0.3%

0.16%

PT/QC/LP/01-6

Test

Specification

Result

Test method

Reference No.

Related Substances

(EP.curr.ed)

Impurity A: NMT 0.5%

Impurity B: NMT 0.5%

Impurity C: NMT 0.5%

Impurity D: NMT 1.0%

Unspecified impurity

 for each impurity: 

NMT 0.5%

Total impurity: NMT 2.5%

None

none

0.33%

none

0.25%(single largest impurity)

0.58%

PT/QC/LP/01-7

Acetic acid

(EP.curr.ed)

4.9%-9%

7.0%

PT/QC/LP/01-8

water

(EP.curr.ed)

NMT 5%

3.5%

PT/QC/LP/01-9

Bacterial Endotoxins

(EP.curr.ed)

Less than 4IU/mg

complies

PT/QC/LP/01-10

Assay

(EP.curr.ed)

97%-103%(anhydrous and acetic acid free substance)

98.60%

PT/QC/LP/01-11

Specific Optical 

Rotation(EP.curr.ed)

-38 to -42(anhydrous and acetic acid free substance)

-40.02

PT/QC/LP/01-12

Residual solvent

Ethenol

Methanol

Acetonitrile

Triethylamine

NMT 5000ppm

NMT 3000ppm

NMT 410 ppm

NMT 320 ppm

Less than LOD 

132ppm

Less than LOD 32ppm

Less than LOD 20ppm

Less than LOD 14ppm

PT/QC/LP/01-13