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High Quality USP/EP/BP GMP DMF FDA Chlorpromazine Tablets CAS NO 50-53-3 Producer
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
| 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
Chlorpromazine Tablets | |
| Action and use | Dopamine receptor antagonist; neuroleptic. |
Definition | Chlorpromazine Tablets contain Chlorpromazine Hydrochloride. They are coated. The tablets comply with the requirements stated under Tablets and with the following requirements. |
| Content of chlorpromazine hydrochloride, C17H19ClN2S,HCl | 92.5 to 107.5% of the stated amount. |
| Identification | A. To a quantity of the powdered tablets containing 40 mg of Chlorpromazine Hydrochloride add 10 ml of water and 2 ml of 10m sodium hydroxide. Shake and extract with 15 ml of ether. Wash the ether layer with two 5 ml quantities of water, dry with anhydrous sodium sulphate and evaporate the ether. Dissolve the residue in 0.4 ml of chloroform. The infrared absorption spectrum of the resulting solution, Appendix II A, is concordant with the reference spectrum of chlorpromazine (RS 056). B. Comply with the test for identification of phenothiazines, Appendix III A. For solution (1) shake a quantity of the powdered tablets with sufficient chloroform to produce a solution containing 0.20% w/v of Chlorpromazine Hydrochloride, centrifuge and use the supernatant liquid. |
Tests Related substances | Comply with the test for related substances in phenothiazines, Appendix III A, using mobile phase A and the following freshly prepared solutions. For solution (1) extract a quantity of the powdered tablets containing 0.1 g of Chlorpromazine Hydrochloride with 10 ml of a mixture of 95 volumes of methanol and 5 volumes of diethylamine and filter. For solution (2) dilute 1 volume of solution (1) to 200 volumes with the same solvent mixture. Dissolution Carry out the procedure protected from light. Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1. test conditions (a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute. (b) Use 900 ml of 0.1m hydrochloric acid, at a temperature of 37°, as the medium. procedure (1) After 45 minutes withdraw a 10 ml sample of the medium and measure the absorbance of the filtered sample, suitably diluted with the dissolution medium to produce a solution containing 0.0005% % w/v of Chlorpromazine Hydrochloride, at the maximum at 254 nm, Appendix II B using 0.1m hydrochloric acid in the reference cell. determination of content Calculate the total content of C17H19ClN2S,HCl, in the medium taking 914 as the value of A(1%, 1 cm) at the maximum at 254 nm. |
Assay | Carry out the following procedure protected from light. Powder 10 tablets without loss, triturate the powder with 10 ml of absolute ethanol, add about 300 ml of 0.1m hydrochloric acid and shake for 15 minutes. Add sufficient 0.1m hydrochloric acid to produce 500 ml, filter, dilute a volume of the filtrate containing 5 mg of Chlorpromazine Hydrochloride to 100 ml with 0.1m hydrochloric acid and further dilute 10 ml to 100 ml with the same solvent. Measure the absorbance of the resulting solution at the maximum at 254 nm, Appendix II B. Calculate the content of C17H19ClN2S,HCl taking 915 as the value of A(1%, 1 cm) at the maximum at 254 nm. |
High Quality USP/EP/BP GMP DMF FDA Chlorpromazine Tablets CAS NO 50-53-3 Producer
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
| 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
Chlorpromazine Tablets | |
| Action and use | Dopamine receptor antagonist; neuroleptic. |
Definition | Chlorpromazine Tablets contain Chlorpromazine Hydrochloride. They are coated. The tablets comply with the requirements stated under Tablets and with the following requirements. |
| Content of chlorpromazine hydrochloride, C17H19ClN2S,HCl | 92.5 to 107.5% of the stated amount. |
| Identification | A. To a quantity of the powdered tablets containing 40 mg of Chlorpromazine Hydrochloride add 10 ml of water and 2 ml of 10m sodium hydroxide. Shake and extract with 15 ml of ether. Wash the ether layer with two 5 ml quantities of water, dry with anhydrous sodium sulphate and evaporate the ether. Dissolve the residue in 0.4 ml of chloroform. The infrared absorption spectrum of the resulting solution, Appendix II A, is concordant with the reference spectrum of chlorpromazine (RS 056). B. Comply with the test for identification of phenothiazines, Appendix III A. For solution (1) shake a quantity of the powdered tablets with sufficient chloroform to produce a solution containing 0.20% w/v of Chlorpromazine Hydrochloride, centrifuge and use the supernatant liquid. |
Tests Related substances | Comply with the test for related substances in phenothiazines, Appendix III A, using mobile phase A and the following freshly prepared solutions. For solution (1) extract a quantity of the powdered tablets containing 0.1 g of Chlorpromazine Hydrochloride with 10 ml of a mixture of 95 volumes of methanol and 5 volumes of diethylamine and filter. For solution (2) dilute 1 volume of solution (1) to 200 volumes with the same solvent mixture. Dissolution Carry out the procedure protected from light. Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1. test conditions (a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute. (b) Use 900 ml of 0.1m hydrochloric acid, at a temperature of 37°, as the medium. procedure (1) After 45 minutes withdraw a 10 ml sample of the medium and measure the absorbance of the filtered sample, suitably diluted with the dissolution medium to produce a solution containing 0.0005% % w/v of Chlorpromazine Hydrochloride, at the maximum at 254 nm, Appendix II B using 0.1m hydrochloric acid in the reference cell. determination of content Calculate the total content of C17H19ClN2S,HCl, in the medium taking 914 as the value of A(1%, 1 cm) at the maximum at 254 nm. |
Assay | Carry out the following procedure protected from light. Powder 10 tablets without loss, triturate the powder with 10 ml of absolute ethanol, add about 300 ml of 0.1m hydrochloric acid and shake for 15 minutes. Add sufficient 0.1m hydrochloric acid to produce 500 ml, filter, dilute a volume of the filtrate containing 5 mg of Chlorpromazine Hydrochloride to 100 ml with 0.1m hydrochloric acid and further dilute 10 ml to 100 ml with the same solvent. Measure the absorbance of the resulting solution at the maximum at 254 nm, Appendix II B. Calculate the content of C17H19ClN2S,HCl taking 915 as the value of A(1%, 1 cm) at the maximum at 254 nm. |
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