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High Quality USP/EP/BP GMP DMF FDA Chlordiazepoxide Capsules CAS NO 58-25-3 Producer

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  • AZ393
  • Dideu
  • 58-25-3
  • C16H14ClN3O
  • 200-371-0
  • China
  • Chlordiazepoxide Capsules
  • High quality
  • 99.0% Min
  • 99%-101%
  • Capsule
  • Solubility in water
  • 1.0% max
  • 0.5% Max
  • 10 ppm Max
  • H-NMR
  • 0.5% Max
  • Medicine

High Quality USP/EP/BP GMP DMF FDA Chlordiazepoxide Capsules  CAS NO 58-25-3 Producer

Product_Description_title


Our Reference Specification, for more details, pls contact us for COA, MSDS and certification:

Email & Skype: Service@dideu.com Telephone:+86-29-89586680

Mobile:+86-15129568250; Whatsapp&Wechat: +8615129568250


Specification_title

Item Standard Test Results
Identification A.H-NMR:Comply with the structure Complies
B.LC-MS:Comply with the structure Complies
C.The IR spectrum of sample should be identical with that of reference standard. Complies
D.HPLC-ESI-MS Complies
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Loss on drying ≤2.0% 0.19%
Heavy metals ≤10 ppm <10ppm
Water ≤1.0% 0.10%
Sulphated ash ≤0.5% determined on 1.0 g. 0.01%
Residue on ignition ≤0.1% 0.03%
Related Substances Unspecified impurities: for each impurity ≤0.10% <0.10%
Total Impurity ≤0.5% 0.18%
Purity ≥99.0% 99.70%
Assay 99.0%~101.0% (anhydrous substance). 99.80%
Storage Preserve in well-closed, light-resistant and airtight containers. Complies





Our Reference Specification, for more details, pls contact us for COA,MSDS and certification:

Email & Skype: support@dideu.com  Telephone:+86-29-89586682

Mobile:+86-15129568250; Whatsapp: +8615129568250

Chlordiazepoxide Capsules 

Action and use

Benzodiazepine.

Definition

Chlordiazepoxide Capsules contain Chlordiazepoxide Hydrochloride.


The capsules comply with the requirements stated under Capsules and with the following requirements.

Content of chlordiazepoxide hydrochloride, C16H14ClN3O,HCl

92.5  to 107.5% of the stated amount.
Identification

A.  Dilute 1  volume of the final solution obtained in the Assay to 2  volumes with 0.1m hydrochloric acid. The light absorption, Appendix II B, in the range 230  to 350  nm exhibits two maxima, at 246  nm and 308  nm.


B.  Shake a quantity of the contents of the capsules containing 25  mg of Chlordiazepoxide Hydrochloride with 2.5  ml of water, add 0.5  ml of 6m ammonia, mix, allow to stand for 5  minutes and filter. The filtrate, after making acidic with 2m nitric acid, yields reaction A characteristic of chlorides, Appendix VI.

Tests

Related substances

Carry out in subdued light the method for thin-layer chromatography, Appendix III A, using silica gel GF254 as the coating substance and a mixture of 85  volumes of chloroform, 14  volumes of methanol and 1  volume of 13.5m ammonia as the mobile phase. Prepare the following solutions immediately before use in acetone containing 2% v/v of 13.5m ammonia and 8% v/v of water. For solution (1) shake a quantity of the contents of the capsules containing 0.10  g of Chlordiazepoxide Hydrochloride with 10  ml of the solvent mixture, allow to settle and use the clear supernatant liquid. For solution (2) dilute 3  volumes of solution (1) to 100  volumes with the same solvent mixture. Solution (3) contains 0.01% w/v of 2-amino-5-chlorobenzophenone. Apply separately to the plate 2-µl and 20-µl quantities of solution (1), 2 µl of solution (2) and 20 µl of solution (3). After removal of the plate, allow it to dry in air and examine under ultraviolet light (254  nm). Any secondary spot in the chromatogram obtained with 2 µl of solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (3%). Spray the plate with a freshly prepared 1% w/v solution of sodium nitrite in 1m hydrochloric acid, dry it in a current of cold air and spray with a 0.4% w/v solution of N-(1-naphthyl)ethylenediamine dihydrochloride in ethanol (96%). Any violet spot corresponding to 2-amino-5-chlorobenzophenone in the chromatogram obtained with 20 µl of solution (1) is not more intense than the spot in the chromatogram obtained with solution (3) (1%).


Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1, using as the medium 900  ml of 0.1m hydrochloric acid and rotating the basket at 100 revolutions per minute. Measure the absorbance of a layer of suitable thickness of the filtered sample, suitably diluted, if necessary, with 0.1m hydrochloric acid at the maximum at 308  nm, Appendix II B. Calculate the total content of chlordiazepoxide hydrochloride, C16H14ClN3O,HCl, in the medium taking 292 as the value of A(1%, 1  cm) at the maximum at 308  nm.

Assay

Carry out the following procedure protected from light. Shake a quantity of the mixed contents of 20 capsules containing 20  mg of Chlordiazepoxide Hydrochloride with 150  ml of 0.1m hydrochloric acid for 20  minutes. Add sufficient 0.1m hydrochloric acid to produce 200  ml and filter. Dilute 10  ml of the filtrate to 50  ml with 0.1m hydrochloric acid and measure the absorbance of the resulting solution at the maximum at 308  nm, Appendix II B. Calculate the content of C16H14ClN3O,HCl taking 292 as the value of A(1%, 1  cm) at the maximum at 308  nm.

Storage

Chlordiazepoxide Capsules should be protected from light.




Packaging&Shipping_title


Our normal packaging is 25kgs/Drum and 200kgs/Drum.

The packaging can be customized. the shipping term can be by sea, by air, and sample or small quantity can be shipped by DHL, FEDEX, EMS and TNT.

Packaging_title

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Shipping_title

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Payment_Terms_title

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Our_Services_title

a) Free sample can be supplied.

b) Guide our clients by professional knowledge and teach them how to use our product after sales.

c) Accept SGS, BV any other third-party inspection before loading.

d) High quality best price Guaranteed.

Our_Services






FAQ_title


Why do you choose Dideu Industries as your partner?

A) High quality can be guaranteed. Dideu Industries since 1975 are reputed chemical manufacturer and are Certified by ISO 9001;2015 and have GMP certification.Free sample can be arranged before shipment and SGS,BV and other third party inspection company are accepted before loading.For regular customers, we accept L/C 180 Days, D/P,D/A payment term. If there is any quality problem after goods arrive. Dideu Industries will do fully payment refund.

B) Best price can be guaranteed. As Dideu Industries are integrated pharmaceuticals and chemicals producer, the production cost can be controlled and price will be definitely more competitive than China trading companies.

C) Professional enginners from Dideu Industries will give professional usage guide and services after sales.

D) Dideu Industries work 7×24 hours and your request will be processed by our professional staff in different shift period.







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