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Meclizine HCL Manufacturing Thailand, the United Kingdom and USA
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Meclizine HCL

  • Product Name : Meclizine HCL
  • Grade : IP / BP / USP
  • Therapeutic Category : Antihistamine
  • CAS No : 1104-22-9
  • Other Name : Meclizine dihydrochloride
  • COA : Available
  • MSDS : Available

Description

Meclizine dihydrochloride

·         Molecular Formula:C25H27ClN2.2(HCl)

·         Molecular Weight:463.87

·         CAS Registry Number:1104-22-9

 

Specification:

 

 

ITEM

STANDARD

RESULTS

Appearance

yellow crystalline powder,odorless

Conforms

Solubility

Easily soluble in water, unsoluble in ethanol

Conforms

PH

6.0~7.5

6.9

Solution clarity and color

solution should be clear and colorless

Conforms

Related substances

5’CMP 0.3%

Simple impurity

Total other impurity

0.01%

0.03%

0.10%

Chloride

0.05%

Conforms

Ammonium

0.05%

Conforms

Fe

0.01%

Conforms

Phosphate

0.1%

Conforms

Loss on drying

≤6.0%

1.3%

Heavy metals

0.002%

Conforms

Arsenide

0.0001%

Conforms

Bacterial Endotoxins

0.3EU/mg

Conforms

Microbial Limit

Conforms

Conforms

Assay(on dried basis)

≥98.0%

98.8%

Conclusion

The results conform with BP 2010

 

Packaging details:

 

 

 

Packaging details:

25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum.

Storage:

Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat

Shelf Life:

5 years if sealed and store away from direct sun light.

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