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Active Pharma Raw Materials

Desloratadine

Desloratadine

We are leading manufacturer and exporter of Desloratadine and our product is made up of good quality.

TEST

SPECIFICATION

Appearance

A white to pink colored crystalline powder.

Solubility

Practically insoluble in water, freely soluble in ethanol (96%) very slightly soluble in heptanes.

Identification:

Infrared Absorption spectrophotometry

 

To match with working/Reference standard.

Related Substance by HPLC

Impurity A

Impurity B

Any individual unspecified impurity

Total Impurities

 

 

NMT 0.2%

NMT 0.3%

NMT 0.10%

NMT 0.4%

Heavy Metals

NMT 20ppm

Water Content

NMT 0.5% w/w

Sulphated Ash

NMT 0.2% w/w

Assay by HPLC

(Anhydrous Basis)

NLT 98.0% NMT 102.0% w/w

Residual Solvents by GC HS

Methanol

Di-isopropyl ether

Methyl isobutyl ketone

Toluene

 

NMT 3000ppm

NMT 10ppm

NMT 5000ppm

NMT 890ppm

Glibenclamide

Glibenclamide

We are leading manufacturer and exporter of Glibenclamide and our product is made up of good quality.

Product NameGlibenclamide BP/EP/USP
Chemical Name5-chloro-N-(4-[N-(cyclohexylcarbamoyl)sulfamoyl]phenethyl)-2-methoxybenzamide
CAS Number10238-21-8
Chemical FormulaC23H28ClN3O5S
Molecular Mass494.01 g/mol
Therapeutic CategoryAntidiabetic

Instructions of Glibenclamide :

TestSpecification
DescriptionWhite or almost white crystalline powder
SolubilityPractically insoluble in water, Sparingly soluble in methylene chloride, slightly soluble in ethanol (95%) and in methanol.
Identification
A) Melting Point
B) By UV

C) By IR

D) By TLC

E) Chemical test

(A) Not less Than 169°C and not more than174°C
(B) Examined between 230nm and 350nm the solution shows an absorption maximum at 300 nm and a less intense maximum at 275nm. the Specific absorbance at the maxima are 61 to 65 and 27 to 32 respectively,
(C) The infra-red absorption spectrum of test substances should be Concordant with the spectrum of Glibenclamide Standard.
(D) The principal spot obtained with the test solution should be similar in Position and size to the prinicipal spot obtained in the chromatogram Obtained with the reference solution.
(E) The solution is colourless and shows blue Fluorescence in ultraviolet light at 365 nm. Colour changes to deep yellow and, after abut 20 minutes develops a brownish tinge with Choral hydrate.
Heavy metalNMT 20ppm
Sulphated AshNMT 0.1 %w/w
Related substances by HPLCImpurity A NMT 0.5 %
Impurity B NMT 0.5 %
Any other Impurity NMT 0.2 %
Two such Peak NMT 0.1 %
Total of other impurities NMT 0.5 %
Loss on drying (at 105°C for three Hours)NMT 1.0%w/w
Assay by Titrimetry on dried basisNLT 99.0%w/w and NMT equivalent of 101.0%w/w
Residual Solvent by HSGCMethanol NMT 3000 ppm
Acetone NMT 5000 ppm
Ethylene dichloride NMT 5 ppm

Imatinib Mesylate

Imatinib Mesylate

We are leading manufacturer and exporter of Imatinib Mesylate and our product is made up of good quality.

Imatinib Mesylate:-

Product NameImatinib Mesylate BP/EP/USP
Chemical Name4 - [(4 - methyl - 1 - piperazinyl)methyl] - N - [4 - methyl - 3 - [[4 - (3 - pyridinyl) - 2 - pyrimidinyl]aminophenyl] - benzamide methanesulfonate salt
CAS Number152459-95-5
Chemical FormulaC29H31N7O • CH4SO3
Molecular Mass589.7 g/mol
Therapeutic CategoryAntineoplastic
Product Type:API

Specification of Imatinib Mesylate :

TestSpecification
DescriptionWhite to off-white Crystalline Powder
Identification By IRIR spectrum of the sample should concordant to the standard spectrum.
SolubilitySoluble in Water
Related substance by HPLCSingle Max. Imp : NMT 0.1 %
Total Max Imp : NMT 1.0 %
Assay (By HPLC)NMT 98.0% And NLT 102 %
ROINMT 0.5%
Heavy metalsNMT 0.5%
Melting range215-220ºC

Ceftriaxone Sodium Sterile

Ceftriaxone Sodium Sterile

We are offering a wide range of Sterile Ceftriaxone Sodium for injectables and pharmaceutical injectables.

The Sterile Ceftriaxone Sodium Injections indicated in respiratory infections. Further, these injections can be availed from us in the reasonable rates.

Specifications:

 

Cetirizine Dihydrochloride

Cetirizine Dihydrochloride

We are leading manufacturer and exporter of Cetirizine Dihydrochloride and our product is made up of good quality.

Characteristics White Crystalline powder

Product NameCetirizine Dihydrochloride BP/EP/USP
Chemical Name-
CAS Number83881-52-1
Chemical FormulaC21H27Cl3N2O3
Molecular Mass-
Therapeutic CategoryAntihistamine

Specification of Cetirizine Dihydrochloride :

TestSpecification
CharacteristicsWhite Crystalline powder
IdentificationA,B,C,D E as per B.P.
SolubilitySoluble in water Methanol
Melting Point210oc to 218oc
pH1.2 to 1.8
Heavy MetalsNot more than 20 ppm
Sulphated AshNot more than 0.2%
Loss On DryingNot more than 0.5%
Related impurities [By TLC]Spot of Ref. Material
Assay On Dried BasisBetween NLT 99.0 % to NMT 100.5%

Cinnarizine EP

Cinnarizine EP

We are leading manufacturer and exporter of Cinnarizine EP and our product is made up of good quality.

Product Type API
Usage Clinical Hospital

Specifications :-

TEST

SPECIFICATION

Description

A white to almost white powder

Solubility

Practically insoluble in water freely soluble in methylene chloride, soluble in acetone, slightly soluble in methanol

Identification

  1. Melting point (118°C-122°C)

  2. IR concurrent with std.spectrum

  3. To Comply

  4. To Comply

Appearance of solution

The solution is clear not more intensely colored than reference standard

Acidity/Alkalinity

For Acidity and point of Solution should be red

For Alkalinity and point of solution should be pink

Related substance

Single impurity : Not More Than 0.25 % w/w of each

Total impurity : Not More Than 0.5 % w/w

Heavy Metals

Not More Than 20 ppm

Loss on drying

Not More Than 0.5 5 w/w

Sulphated Ash

Not More Than 0.1 % w/w

Assay

99.0 % w/w to 101.0 % w/w

Desloratidine

Desloratidine

We are leading manufacturer and exporter of Desloratidine and our product is made up of good quality.

Product NameDesloratidine BP/EP/USP
Chemical Name8-Chloro-6,11-Dihydro-11-(4-Piperdinylidene)- 5H-Benzo [5,6] Cyclohepta[1,2-B]Pyridine
CAS Number100643-71-8
Chemical FormulaC19H19ClN2
Molecular Mass310.82 G/Mol
Therapeutic CategoryAntihistamine

Specification of Desloratidine :

TestSpecification
DescriptionA White To Light Brown Colored Crystalline Powder
SolubilityFreely Soluble In Methanol.
Identification
A) By IR
The IR Spectrum Of The Sample Recorded As KBr Pellet Is Concordant With Similarly Recorded Spectrum Of Working Standard.
Water Content By KFNMT 1.0%
Melting RangeBetween 152oC To 159oC
Heavy MetalsNot More Than 20 Ppm
Sulphated AshNot More Than 0.10% W/W
Additional Test Residual Solvents (By GC)Single Max Impurity: N MT 0.10 %
Total Impurities: NMT 0.30 %
Ssay (On Anhydrous Basis)ANot Less Than 99.0% And NMT 101.0%

Fluconazole

Fluconazole

Fluconazole is White or almost white crystalline powder with following specifications.

Product NameFluconazole BP/EP/USP
Chemical Name2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol
CAS Number86386-73-4
Chemical FormulaC13H12F2N6O
Molecular Mass306.27 g/mol
Therapeutic CategoryAntifungal

Specification of Fluconazole :

TestSpecification
DescriptionWhite or almost white crystalline powder
SolubilityFreely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropanol and in chloroform, slightly soluble in water, very slightly soluble in toluene.
Appearance of solution5%w/v Solution in methanol should be clear and colorless
Identification
By IR test

By UV test

Determine by infrared absorption spectrophotometry compare the spectrum with the obtained with fluconzole RS or with the reference spectrum of fluconzole.
When examined in the range 200 nm to 350 nm, a 0.025%w/v solution in methanol shows absorption maxima at about 266nm and 261 nm
Loss on DryingNMT 0.50%
Sulphated ashNMT 0.10%
Iron test20 ppm
Related Compound by HPLC (TEST-1)Impurity A : NMT 0.20%
Impurity about RRT 0.6 : NMT 1.00 %
Related Compound B : NMT 0.10 %
Related Compound C : NMT 0.20 %
Any single maximum
Unknown Impurity : NMT 0.10 %
Total unknown impurities : NMT 0.30 %
Total Impurities : NMT 1.50 %
Assay ( on Anhydrous basis )NLT 98.00% and NMT 102.00%w/w
Residual Solvents
- Methyl Chloride
- Ethyl acetate
- Toluene
- Methanol
- Acetone
- Isopropyl alcohol
- Benzene

NMT 500 ppm
NMT 1000 ppm
NMT 890 ppm
NMT 1000 ppm
NMT 1000 ppm
NMT 1000 ppm
NMT 2 ppm

Fluconazole

Fluconazole

We are leading manufacturer and exporter of Fluconazole and our product is made up of good quality.

Product NameFluconazole BP/EP/USP
Chemical Name2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol
CAS Number86386-73-4
Chemical FormulaC13H12F2N6O
Molecular Mass306.27 g/mol
Therapeutic CategoryAntifungal

Specification of Fluconazole :

TestSpecification
DescriptionWhite or almost white crystalline powder
SolubilityFreely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropanol and in chloroform, slightly soluble in water, very slightly soluble in toluene.
Appearance of solution5%w/v Solution in methanol should be clear and colorless
Identification
By IR test

By UV test

Determine by infrared absorption spectrophotometry compare the spectrum with the obtained with fluconzole RS or with the reference spectrum of fluconzole.
When examined in the range 200 nm to 350 nm, a 0.025%w/v solution in methanol shows absorption maxima at about 266nm and 261 nm
Loss on DryingNMT 0.50%
Sulphated ashNMT 0.10%
Iron test20 ppm
Related Compound by HPLC (TEST-1)Impurity A : NMT 0.20%
Impurity about RRT 0.6 : NMT 1.00 %
Related Compound B : NMT 0.10 %
Related Compound C : NMT 0.20 %
Any single maximum
Unknown Impurity : NMT 0.10 %
Total unknown impurities : NMT 0.30 %
Total Impurities : NMT 1.50 %
Assay ( on Anhydrous basis )NLT 98.00% and NMT 102.00%w/w
Residual Solvents
- Methyl Chloride
- Ethyl acetate
- Toluene
- Methanol
- Acetone
- Isopropyl alcohol
- Benzene

NMT 500 ppm
NMT 1000 ppm
NMT 890 ppm
NMT 1000 ppm
NMT 1000 ppm
NMT 1000 ppm
NMT 2 ppm

Fluticasone Propionate

Fluticasone Propionate

We are leading manufacturer and exporter of Fluticasone Propionate and our product is made up of good quality.

Instructions:-

Application-Anti-Infective

Grade standard-Medicine Grade

Form Of Medicines-Powder

Gemcitabine Hydrochloride

Gemcitabine Hydrochloride

We are leading manufacturer and exporter of Gemcitabine Hydrochloride and our product is made up of good quality.

Gemcitabine Hydrochloride is White or almost white crystal.

Product NameGemcitabine Hydrochloride BP/EP/USP
Chemical Name5-chloro-N-(4-[N-(cyclohexylcarbamoyl)sulfamoyl]phenethyl)-2-methoxybenzamide
CAS Number10238-21-8
Chemical FormulaC23H28ClN3O5S
Molecular Mass494.01 g/mol
Therapeutic CategoryAntidiabetic

Instructions of Glibenclamide :

TestSpecification
DescriptionWhite or almost white crystalline powder
SolubilityPractically insoluble in water, Sparingly soluble in methylene chloride, slightly soluble in ethanol (95%) and in methanol.
Identification
A) Melting Point
B) By UV

C) By IR

D) By TLC

E) Chemical test

(A) Not less Than 169°C and not more than174°C
(B) Examined between 230nm and 350nm the solution shows an absorption maximum at 300 nm and a less intense maximum at 275nm. the Specific absorbance at the maxima are 61 to 65 and 27 to 32 respectively,
(C) The infra-red absorption spectrum of test substances should be Concordant with the spectrum of Glibenclamide Standard.
(D) The principal spot obtained with the test solution should be similar in Position and size to the prinicipal spot obtained in the chromatogram Obtained with the reference solution.
(E) The solution is colourless and shows blue Fluorescence in ultraviolet light at 365 nm. Colour changes to deep yellow and, after abut 20 minutes develops a brownish tinge with Choral hydrate.
Heavy metalNMT 20ppm
Sulphated AshNMT 0.1 %w/w
Related substances by HPLCImpurity A NMT 0.5 %
Impurity B NMT 0.5 %
Any other Impurity NMT 0.2 %
Two such Peak NMT 0.1 %
Total of other impurities NMT 0.5 %
Loss on drying (at 105°C for three Hours)NMT 1.0%w/w
Assay by Titrimetry on dried basisNLT 99.0%w/w and NMT equivalent of 101.0%w/w
Residual Solvent by HSGCMethanol NMT 3000 ppm
Acetone NMT 5000 ppm
Ethylene dichloride NMT 5 ppm

Imatinib Mesylate

Imatinib Mesylate

We are leading manufacturer and exporter of Imatinib Mesylate and our product is made up of good quality.

Product NameImatinib Mesylate BP/EP/USP
Chemical Name4 - [(4 - methyl - 1 - piperazinyl)methyl] - N - [4 - methyl - 3 - [[4 - (3 - pyridinyl) - 2 - pyrimidinyl]aminophenyl] - benzamide methanesulfonate salt
CAS Number152459-95-5
Chemical FormulaC29H31N7O • CH4SO3
Molecular Mass589.7 g/mol
Therapeutic CategoryAntineoplastic

Specification of Imatinib Mesylate :

TestSpecification
DescriptionWhite to off-white Crystalline Powder
Identification By IRIR spectrum of the sample should concordant to the standard spectrum.
SolubilitySoluble in Water
Related substance by HPLCSingle Max. Imp : NMT 0.1 %
Total Max Imp : NMT 1.0 %
Assay (By HPLC)NMT 98.0% And NLT 102 %
ROINMT 0.5%
Heavy metalsNMT 0.5%
Melting range215-220ºC

Itraconazole BP/EP

Itraconazole BP/EP

We are leading manufacturer and exporter of Itraconazole BP/EP and our product is made up of good quality.
Description A white or almost white powder.
Product NameItraconazole BP/EP/USP
Chemical Name(2R,4S)-rel-1-(butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl] methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one
CAS Number84625-61-6
Chemical FormulaC35H38Cl2N8O4
Molecular Mass705.64 g/mol
Therapeutic CategoryAntifungal

Specification of Itraconazole :

TestSpecification
DescriptionA white or almost white powder.
SolubilityPractically insoluble in water, freely soluble in Methylene chloride, sparingly soluble in Tetrahydrofuran, very slightly soluble in alcohol
Identification By IRThe infra Red absorption spectrum of the finely ground sample in KBr dispersion compressed into a disc should exhibit maxima only at the same wavelengths as that of similar preparation of Itraconazole Working Standard
Appearance of solutionA solution of 2 g in 20ml Methylene chloride should be clear and not more intensely coloured than BY6
Optical Rotation-0.10º to 0.10º
Related substances HPLCMaximum Single impurity : NMT 0.5%
Total Impurities : NMT 1.25%
Loss on dryingNMT 0.5%w/w
Sulphated AshNMT 0.1%w/w
Assay on dried basisNLT 98.5% and NMT 101.5% w/w

Salmetrol Xinpoate

Salmetrol Xinpoate

We are leading manufacturer and exporter of Salmetrol Xinpoate and our product is made up of good quality.

Trihexyphenydyl HCL

Trihexyphenydyl HCL

Trihexyphenidyl is used to treat all forms of parkinsonism, including Parkinson’s disease.

This drug is also used to treat severe movement side effects caused by antipsychotic drugs (drug-induced movement disorders).

Instructions:

Trimicilone Acetonide

Trimicilone Acetonide

We are leading manufacturer and exporter of Trimicilone Acetonide and our product is made up of good quality.

Drug Additives

Drug Additives

Our organization holds expertise in providing superior grade Active Pharmaceutical Ingredient (API) to our customers. Our offered API’S are widely appreciated by our customers, which are situated all round the world.

Known for its best quality, clients can avail this Active Pharmaceutical Ingredient (API) at industry leading prices from us.

Instructions:

Voriconazole

Voriconazole

We are leading manufacturer and exporter of Voriconazole and our product is made up of good quality.

Lansoprazole

Lansoprazole

We are leading manufacturer and exporter of Lansoprazole and our product is made up of good quality.

Lansoprazole is a medication which inhibits the stomach's production of acid.

There is no evidence that its effectiveness is different from that of other PPIs
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    Sanjay Totre

    (Managing Director)

    Yashica Pharmaceuticals Private Limited

    Syndicate, Thane, Maharashtra, India

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