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AZ300
Dideu
500-92-5
C11H16ClN5
207-915-6
China
Proguanil Tablets
High quality
99.0% Min
99%-101%
Tablet
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 Proguanil Tablets CAS NO 500-92-5 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
Proguanil Tablets | |
Action and use | Antiprotozoal (malaria). |
Definition | Proguanil Tablets contain Proguanil Hydrochloride. The tablets comply with the requirements stated under Tablets and with the following requirements. |
Content of proguanil hydrochloride, C11H16ClN5,HCl | 95.0 to 105.0% of the stated amount. |
Identification | A. To a quantity of the powdered tablets containing 0.2 g of Proguanil Hydrochloride add 25 ml of methanol, shake for 10 minutes, filter, evaporate the filtrate to dryness and dry the residue at 105°. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of proguanil hydrochloride (RS 294). B. Boil a quantity of the powdered tablets containing 0.5 g of Proguanil Hydrochloride with 5 ml of 2m hydrochloric acid, cool and filter. To the filtrate add a slight excess of 5m sodium hydroxide, extract with 30 ml of ether, evaporate the ether and dry the residue at 105°. The melting point of the residue is about 131°, Appendix V A. |
Tests
Related substances | 4-Chloroaniline To a quantity of the powdered tablets containing 0.1 g of Proguanil Hydrochloride add 5 ml of ethanol (96%) and shake for 10 minutes. Add 2.5 ml of 2m hydrochloric acid and 15 ml of water, mix and filter through a moistened filter paper, washing the filter with 5 ml of water. Cool the filtrate to 5°, add 1 ml of 0.05m sodium nitrite, allow to stand at 5° for 5 minutes, add 2 ml of a 5% w/v solution of ammonium sulphamate and allow to stand for 10 minutes. Add 2 ml of a 0.1% w/v solution of N-(1-naphthyl)ethylenediamine dihydrochloride, dilute to 50 ml with water and allow to stand for 30 minutes. Any magenta colour produced is not more intense than that obtained by treating in the same manner and at the same time 20 ml of a solution containing 1.25 µg per ml of 4-chloroaniline (250 ppm). Related substances Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) add 50 ml of methanol to a quantity of the powdered tablets containing 0.1 g of Proguanil Hydrochloride, shake for 10 minutes, dilute to 100 ml with methanol, mix, filter and dilute 5 ml of the filtrate to 50 ml with the mobile phase. For solution (2) dilute 1 volume of solution (1) to 100 volumes with the mobile phase. For solution (3) mix 1 volume of a 0.05% w/v solution of 1-(2,5-dichlorophenyl)-5-isopropylbiguanide hydrochloride BPCRS in methanol with 9 volumes of a 0.010% w/v solution of proguanil hydrochloride BPCRS in the mobile phase. The chromatographic procedure may be carried out using (a) a stainless steel column (10 cm × 5 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil C18 is suitable) and maintained at 40°, (b) as the mobile phase with a flow rate of 1 ml per minute a solution prepared by dissolving 1.89 g of sodium hexanesulphonate in a mixture of 500 ml of methanol, 500 ml of water and 5 ml of glacial acetic acid and (c) a detection wavelength of 254 nm. The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated peaks due to proguanil hydrochloride and 1-(2,5-dichlorophenyl)-5-isopropylbiguanide hydrochloride. The sum of the areas of any secondary peaks in the chromatogram obtained with solution (1) is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%). Dissolution Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1, using Apparatus 2. Use as the medium 900 ml of 0.2m hydrochloric acid containing 0.2% w/v of sodium chloride and rotate the paddle at 50 revolutions per minute. Withdraw a sample of 10 ml of the medium, filter and dilute 2 ml of the filtrate to 10 ml with dissolution medium. Measure the absorbance of this solution, Appendix II B, at 242 nm using dissolution medium in the reference cell. Measure the absorbance of a 0.001% w/v solution of proguanil hydrochloride BPCRS in dissolution medium using dissolution medium in the reference cell. Calculate the total content of proguanil hydrochloride, C11H16ClN5,HCl, in the medium from the absorbances obtained and from the declared content of C11H16ClN5,HCl in proguanil hydrochloride BPCRS. |
Assay | Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) weigh and powder 20 tablets, add 50 ml of methanol to a quantity of the powdered tablets containing 0.1 g of Proguanil Hydrochloride, shake for 10 minutes, dilute to 100 ml with methanol, mix and filter. To 5 ml of the filtrate add sufficient methanol to produce 50 ml and dilute 10 ml of the resulting solution to 50 ml with the mobile phase. Solution (2) contains 0.002% w/v of proguanil hydrochloride BPCRS in the mobile phase. For solution (3) mix 1 volume of a 0.05% w/v solution of 1-(2,5-dichlorophenyl)-5-isopropylbiguanide hydrochloride BPCRS in methanol with 9 volumes of a 0.010% w/v solution of proguanil hydrochloride BPCRS in the mobile phase. The chromatographic procedure described under Related substances may be used. The assay is not valid unless the chromatogram obtained with solution (3) shows two clearly separated peaks due to proguanil hydrochloride and 1-(2,5-dichlorophenyl)-5-isopropylbiguanide hydrochloride. Calculate the content of C11H16ClN5,HCl in the tablets using the declared content of C11H16ClN5,HCl in proguanil hydrochloride BPCRS. |
Impurities | The impurities limited by the requirements of this monograph include those listed in the monograph for Proguanil Hydrochloride. |
High Quality USP/EP/BP GMP DMF FDA Proguanil Tablets CAS NO 500-92-5 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
Proguanil Tablets | |
Action and use | Antiprotozoal (malaria). |
Definition | Proguanil Tablets contain Proguanil Hydrochloride. The tablets comply with the requirements stated under Tablets and with the following requirements. |
Content of proguanil hydrochloride, C11H16ClN5,HCl | 95.0 to 105.0% of the stated amount. |
Identification | A. To a quantity of the powdered tablets containing 0.2 g of Proguanil Hydrochloride add 25 ml of methanol, shake for 10 minutes, filter, evaporate the filtrate to dryness and dry the residue at 105°. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of proguanil hydrochloride (RS 294). B. Boil a quantity of the powdered tablets containing 0.5 g of Proguanil Hydrochloride with 5 ml of 2m hydrochloric acid, cool and filter. To the filtrate add a slight excess of 5m sodium hydroxide, extract with 30 ml of ether, evaporate the ether and dry the residue at 105°. The melting point of the residue is about 131°, Appendix V A. |
Tests
Related substances | 4-Chloroaniline To a quantity of the powdered tablets containing 0.1 g of Proguanil Hydrochloride add 5 ml of ethanol (96%) and shake for 10 minutes. Add 2.5 ml of 2m hydrochloric acid and 15 ml of water, mix and filter through a moistened filter paper, washing the filter with 5 ml of water. Cool the filtrate to 5°, add 1 ml of 0.05m sodium nitrite, allow to stand at 5° for 5 minutes, add 2 ml of a 5% w/v solution of ammonium sulphamate and allow to stand for 10 minutes. Add 2 ml of a 0.1% w/v solution of N-(1-naphthyl)ethylenediamine dihydrochloride, dilute to 50 ml with water and allow to stand for 30 minutes. Any magenta colour produced is not more intense than that obtained by treating in the same manner and at the same time 20 ml of a solution containing 1.25 µg per ml of 4-chloroaniline (250 ppm). Related substances Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) add 50 ml of methanol to a quantity of the powdered tablets containing 0.1 g of Proguanil Hydrochloride, shake for 10 minutes, dilute to 100 ml with methanol, mix, filter and dilute 5 ml of the filtrate to 50 ml with the mobile phase. For solution (2) dilute 1 volume of solution (1) to 100 volumes with the mobile phase. For solution (3) mix 1 volume of a 0.05% w/v solution of 1-(2,5-dichlorophenyl)-5-isopropylbiguanide hydrochloride BPCRS in methanol with 9 volumes of a 0.010% w/v solution of proguanil hydrochloride BPCRS in the mobile phase. The chromatographic procedure may be carried out using (a) a stainless steel column (10 cm × 5 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil C18 is suitable) and maintained at 40°, (b) as the mobile phase with a flow rate of 1 ml per minute a solution prepared by dissolving 1.89 g of sodium hexanesulphonate in a mixture of 500 ml of methanol, 500 ml of water and 5 ml of glacial acetic acid and (c) a detection wavelength of 254 nm. The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated peaks due to proguanil hydrochloride and 1-(2,5-dichlorophenyl)-5-isopropylbiguanide hydrochloride. The sum of the areas of any secondary peaks in the chromatogram obtained with solution (1) is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%). Dissolution Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1, using Apparatus 2. Use as the medium 900 ml of 0.2m hydrochloric acid containing 0.2% w/v of sodium chloride and rotate the paddle at 50 revolutions per minute. Withdraw a sample of 10 ml of the medium, filter and dilute 2 ml of the filtrate to 10 ml with dissolution medium. Measure the absorbance of this solution, Appendix II B, at 242 nm using dissolution medium in the reference cell. Measure the absorbance of a 0.001% w/v solution of proguanil hydrochloride BPCRS in dissolution medium using dissolution medium in the reference cell. Calculate the total content of proguanil hydrochloride, C11H16ClN5,HCl, in the medium from the absorbances obtained and from the declared content of C11H16ClN5,HCl in proguanil hydrochloride BPCRS. |
Assay | Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) weigh and powder 20 tablets, add 50 ml of methanol to a quantity of the powdered tablets containing 0.1 g of Proguanil Hydrochloride, shake for 10 minutes, dilute to 100 ml with methanol, mix and filter. To 5 ml of the filtrate add sufficient methanol to produce 50 ml and dilute 10 ml of the resulting solution to 50 ml with the mobile phase. Solution (2) contains 0.002% w/v of proguanil hydrochloride BPCRS in the mobile phase. For solution (3) mix 1 volume of a 0.05% w/v solution of 1-(2,5-dichlorophenyl)-5-isopropylbiguanide hydrochloride BPCRS in methanol with 9 volumes of a 0.010% w/v solution of proguanil hydrochloride BPCRS in the mobile phase. The chromatographic procedure described under Related substances may be used. The assay is not valid unless the chromatogram obtained with solution (3) shows two clearly separated peaks due to proguanil hydrochloride and 1-(2,5-dichlorophenyl)-5-isopropylbiguanide hydrochloride. Calculate the content of C11H16ClN5,HCl in the tablets using the declared content of C11H16ClN5,HCl in proguanil hydrochloride BPCRS. |
Impurities | The impurities limited by the requirements of this monograph include those listed in the monograph for Proguanil Hydrochloride. |
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.
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.
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.
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.
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.
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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