Product

Homatropine methylbromide

Batch No

20091201

Manufacturing date

Dec 04,2009

Reported Date

Dec 07,2009

Batch Size

20 kgs

Exp. Date

Nov, 2012

According to

EP6/USP30

Packaging

1kg /packing

Items

Specification

Results

Description

(Visual test)

A white crystalline powder or colorless crystals.

White crystalline powder

Solubility(Visual test)

Freely soluble in water, soluble in alcohol

Conforms

Identification

IR      should    be       complied          with        Homatropine

methylbromide CRS

Conforms

HPLC  Retention  time   The  retention  time  of  principle peak  obtained  with  the  test  sample  is  the  same  as  that obtained with the reference standard.

Conforms

UV   Absorptivities  at  258  nm,  calculated  on  the  dried basis, do not differ by more than 3.0%.

Conforms

Mercuric-potassium  iodide TS  produces  in  a  solution  (1 in  50)  a  white  or  slightly  yellowish  precipitate,  but  no precipitation  is  caused  by solutions  of alkali hydroxides or   carbonates,   even   in   concentrated   solutions  of  the substance (distinction from most alkaloids).

Conforms

To a solution (1 in 50), add ammonium reineckate TS  a red precipitate is formed.

Conforms

Dissolve 50 mg in 1 ml of water R and add 2 ml of dilute acetic acid R. Heat and add 4 ml of picric acid solution R. Allow to cool, shaking occasionally. The crystals washed with 2 quantities, each of 3 ml, of iced water R and dried at 100-105 °C melt (2.2.14) at 132 °C to 138 °C.

Conforms

Bromide tests positive

Conforms

Melting point

About 190°C

193°C

PH

5% aqueous solution  between 4.5 and 6.5

5.3

1% aqueous solution  between 4.5 and 6.5

5.5

Appearance of

Solution

Clear and colorless

Clear and colorless

Related substances

Impurity A,B not more than 0.5%

<0. 1%

Impurity C,D,E,F not more than 0.1%

<0. 1%

Any other impurity  not more than 0.1%

Not detected

Total impurity not more than 1.0%

<0. 5%

Purity

Homatropine,  atropine,  and  other  solanaceous  alkaloids  Not detectable

Not detected

Loss of drying

Not more than 0.5%

0.02%

Organic volatile impurities

A test for stated impurities listed in USP 29 under<467> is  not  carried  out  since  they  do  not  appear  in  Beijing Merson Pharma route of synthesis.

Conforms

Residual solvents

Acetone not more than 1000ppm

110ppm

Ethanol not more than 5000ppm

1080ppm

Chloroform not more than 60ppm

Not detected

Sulphated ash

Not more than 0.1%.

0.02%

Assay

Titrate with perchloric acid 98.5%~100.5%

99.9%

Titrate with silver nitrate  98.5%~101.0%

99.8%

Liquid Chromatography  98%~102%

99.7%

Conclusion

Homatropine  methylbromide  Conforms  with  the  requirements  of  EP6/USP30

Standard