Guaifensin and Dextromethorphan Hydrobromide Tablets

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Processing Time: 1 Days - 60 Days

Packaging Details: STANDARD EXPORTING PACKAGE

Port: Shanghai / Shenzhen / Qingdao / Ningbo / Other

Payment Terms: L/C , T/T , other

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Basic Information

Therapeutic Use

Codeine
Branded Name

Ketan(R)
Strength

12 Tab/24 Tab

Brief description

Specifications

1. Product name: dextromethorphan hydrobromide
2. Appearance: white or white-like crystal powder

Detailed description

Product Information:

1. Product name: Dextromethorphan hydrobromide

2. Specification: 99%

3. Appearance: white or white-like crystal powder

4. CAS No.: 125-69-9

5. Molecular formula: C18H25NO.HBr.H2O

Package details: 25kg/drum with two plastic-bags inside or as your requirement

CAS Number

6700-34-1

Molecular Formula

C18H25NO.HBr.H2O

Standard

USP32, BP2009, JP15

Certificate

ISO

Certification

GMP

Package

1kg/tin; 25kg/drum

Usage:

The primary use of dextromethorphen hydrobromide is as an antitussive, or cough suppressant. This is one of the most popular ingredients in over-the-counter cold and cough medications. This medication may be added to other preparations to help treat pain and a variety of other disturbances as well; Dry cough

Dextromethorphen Hydrobromide Anhydrous is also available.

Product name	Dextromethorphan hydrobromide
Batch No.	KNCA0116		Sample quantity		50.00 gm
A.R.NO	10000421898		Date of analysis		03.12.2009
Manufacture date	DEC.2009		Expiry date		NOV.2014
Ref. standard	USP32		Packing		50g/bag
TEST		RESULT		SPECIFICATION
Description		White crystalline powder		Practically white crystals or crystalline powder having a faint odour.
Solubility		Complies		Sparingly soluble in water, freely soluble in alcohol and in chloroform and insoluble in ether.
Identification by a. IR		Complies		The infrared absorption spectrum of finely ground sample in potassium bromide dispersion compressed into a pellet, exhibits maxima only at the same wave lengths as that of a similar preparation of the corresponding Dextromethorphan HBr WS
b. UV absorption		1.58%		Absorbtivity at 278nm of sample (100μg/ml(on anhydrous basis)solution in 0.1N hydrochloric acid) do not differ from a similar preparation of Dextromethorphan Hydrobromide WS by more than 3.0%
c. With silver Nitrate TS		Complies		A yellowish wihte precipitate formed when 5 drops of 2N nitric acid and 2ml of silver nitrate TS are added to 5ml of sample solution.
Melting point		126.5°C with decomposition		Melts at about 126°C with decomposition.
Specific optical rotation at 25°		0.30%		The specific rotation of the sample at 325nm do (on anhydrous basis) not differ from a similar preparation of (C=1,8 in water) Dextromethorphan hydrobromic WS, by more than 1.0%
Ph (1 in 100)		6.38		Between 5.20 and 6.50
Water by KF		4.45% w/w		Between 3.5and 5.5% w/w
Residue on ignition		0.04% than 0.001%		Not more than 0.1% w/w
Limit of N,N-dimethylaniline		Less than 0.001%		Not more than 0.001%
Limit of phenolic compounds		Complies		No blue-green colour develops
Assay (on anhydrous basis)		99.58% w/w		Not less than 98.0% and Not less than 102.0% w/w

Company Profile

Merro Pharmaceutical Co., Ltd.

Merro Pharmaceutical Co., Ltd. is a public listed company specializing in R&D, manufacturing and marketing of pharmaceutical products, with registered capital of 350 million yuan, which covers a land of 155,000 square meters and the built-up area is 130,000 square meters. "Merro" is rated as the famous trademark of China and it is a national high-tech enterprise.

Merro has been devoted to the development, manufacture and sales of chemical medicine, biological medicine, Chinese traditional medicine and herbal medicine and Merro is a leading company in the pharmaceutical field. Merro’s core strategies are: developing and manufacturing of National Essential Drugs, Generic drugs and Biomedicines; focusing on ER preparation and biologicals; collaborating widely with international pharmaceutical markets; improving the company’s innovation capability and becoming an international pharmaceutical company with high technology, superior service and adaptability to changes.

Merro has all the manufacturing equipment and analytical instrument up to worldwide standard. Merro represents a Brand that enjoys nationwide reputation among the professionals and consumers for the quality. Merro pursues partners worldwide for new products and technology to evolve into a company with specialty, standardization and worldwide presence. Merro has more than 300 employees with technical background and more than 100 on pharmaceutical certifications, majority of whom enjoys decent English proficiency. This provides the foundation for the overseas business strategy. Besides, the company has also been rewarded more than 30 honors, such as “Excellent Enterprise in National Pharmaceutical Industry”. Merro will assure more responsibility to society and promote the common prosperity of the company and the community.