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OUR PRODUCTS |
Active Pharma Ingredients | Pharma Intermediates | Under Developments |
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PRODUCT SPECIFICATIONS |
Active Pharma Ingredients | Pharma Intermediates |
| Bisacodyl BP/USP | |
| Specification | For : Bisacodyl B.P |
| Test | Specification |
| Description | White Crystalline Powder |
| Solubility | Practically insoluble in water, soluble in acetone, sparingly soluble in alcohol, slightly soluble in ether. It dissolves in dilute mineral acids |
| Identification | A) Melts between 131°C-
135°C B) U.V. Absorption. C) IR D) TLC- Complies. |
| Acidity or Alkalinity | NMT 0.4 ml of 0.01M HCl required to change the colour. |
| Related substance(TLC) | Should be single spot |
| Sulphated Ash | Limit : Max. 0.1% |
| Loss on Drying [100°C-105°C] | Limit : Max. 0.5% |
| Assay | Limit: 98 % to 101% |
| (On Dried Basis) | |
| Eosin Disodium FRP | |
| Specification | For : Eosin Yellow Sodium Salt FRP |
| Test | Specification |
| Description | Brownish red powder |
| Identification | A. Test Passes B. Test Passes C. Test Passes D. Test Passes E. Test Passes |
| Solubility 0.1 %( In Water) | Clear reddish yellow solution |
Absorptivity (A1%,1CM Water max) |
Limit :1200-1400 |
| Absorption Maximum (Water
max) |
Limit : 515-518 NM |
| Combined ether extracts | Mass of residue : Max.0.5% |
| Related Substances | Complies |
| Chloride | Limit : Max. 1% |
| Sulphated Ash | Limit : 20 to 23% |
| Insoluble Matter | Limit : Max 0.2 % |
| Loss On Drying (At 1100C 1HR) | Limit : Max 8% |
| Ether | Limit : Max.0.5% |
| Assay | Limit : Min. 87 % |
| pH (a 2% solution in distilled water) | Limit : 7.0 to 8.0 |
| Lead (as Pb) | Limit : Max. 20 PPM |
| Arsenic (as As) | Limit : Max. 3 PPM |
| Fluticasone Propionate | |
| Specification | For : Fluticasone Propionate [S-Fluoromethyl 6a, 9 a ? difluoro-11B-hydroxy-16 a-methyl-3-oxo-17 a-propionyloxyandrosta-1,4-diene- 17B-carbothioate.] |
| CAS No. | [80474-14-2] |
| Molecular formula | C25H31F3O5S |
| Molecular weight | 500.6 |
| Test | Specification |
| Description | A White or almost white crystalline powder |
| Identification | IR absorption spectrum |
| Solubility | Practically insoluble in water, sparingly soluble in methylene choloride, slightly soluble in alcohol |
| Specific Ooptical Rotation at 200 | Between + 32 to + 36 |
| Water Content | Limit : Max. 0.5 % |
| Heavy Metals | Limit : Max.20 PPM |
| Related Substances (Chromatographic purity) (by HPLC) | 1) Impurity A : Max. 0.2 % 2) Impurity B :Max. 0.2 % 3) Impurity C : Max. 0.2 % 4) Impurity D : Max. 0.3% 5) Impurity E : Max. 0.2 % 6) Impurity F :Max. 0.2 % 7) Impurity G :Max.0.3 % 8) Impurity H :Max. 0.2 % 9) Impurity I : Max. 0.2 % 10) Other impurity : Max. 0.1 % 11) Total impurity Max. 1.2 % |
| Residual Solvents Acetone | 2000 PPM |
| Particle Size | Limit : 100 % less than 20 Microns |
| Assay by HPLC (On Dry Basis) | Limit : 97.0 % & 102.0 % |
| Methylene Blue EP | |
| C.I. No. | 52015 |
| CAS No. | 61-73-4 |
| Test | Specification |
| Description | Dark greenish powder |
| Identification | A) Test passes B) Test passes C) Test passes D) Test passes |
| Solubility 0.1% (Water) | Clear Blue Solution, Soluble in water, slightly soluble in Alcohol, practically insoluble in Ether |
| Absorptivity 1%, 1cm, at λ Max. 664.0nm | Limit : 2200-2750 |
| Methanol Insoluble Substances | Limit: Max.1.0% |
| Related Colorants | As per EP |
| Heavy Metals | Limit: Max. 20PPM |
| Iron | Limit : Max.100PPM |
| Zinc | Limit: Max.100PPM |
| Loss On Drying (At 110° C) | Limit: 10-15% |
| Sulfated Ash | Limit : Max. 0.25% |
| Assay | Limit: 95% to 101% |
| (On Dried Basis) | |
| Phenytoin Base B. P | |
| Specification | For : Phenytoin Base B. P |
| Test | Specification |
| Description | Almost white crystalline powder, odourless |
| Identification | A) I. R. Test passes B) T.L.C. Test Passes C).Test Passes D).Test Passes |
| Solubility | Practically insoluble in water, sparingly soluble in alcohol, very slightly soluble in Methylene chloride |
| Clarity And Color of Solution | Clear & colorless solution |
| Acidity Or Alkalinity | As per B.P. |
| Related Substance | As per B.P. |
| Heavy Metals | Limit: 10 PPM |
| Loss On Drying | Limit : Max. 0.5% |
| Sulphated Ash | Limit :Max. 0.1% |
| Assay | Limit: 99 % to 101% |
| Phenytoin Sodium BP / EP | |
| Specification | For : Phenytoin Sodium BP |
| Test | Specification |
| Description | A white, crystalline power, hygroscopic |
| Identification | A) I. R. Test passes B) Test passes C) Test passes |
| Clarity And Colour of Solution | As per BP |
| Heavy Metals | Limit: Max.10 PPM |
| Free Phenytoin | Limit : 0.1 normal NaoH Sodium Hydroxide |
| Related Substance/TLC | By TLC Passes |
| Water Content | Limit : Max. 3.0% |
| Assay | Limit : 98.5% to 100.5% |
| Picosulfate Sodium BP/USP | |
| Specification | For : Sodium Picosulfate BP |
| Test | Specification |
| Description | A white or almost white crystalline powder |
| Identification | A) I. R. should confirm B) TLC as per Related Substance C)Chemical Test D) Chemical Test E) Gives reaction of Sodium |
| Solubility | Freely soluble in water, slightly soluble in alcohol |
| Appearance of Solution | The solution should clear and not more intensely colored than reference solution GY7 |
| Acidity Or Alkalinity | The solution is colourless. NMT 0.25 ml of 0.01 M NaOH is required to change the colour of the indicator of peak |
| Related Substance | Limit : Max. 0.2% |
| Chloride | Limit : Max. 200 PPM |
| Sulphate | Limit : Max. 400 PPM |
| Heavy Metals | Limit: Max. 1 PPM |
| Water Content | Limit : 3.0% - 5.0% |
| Assay O.D.B. (by Titration) | Limit: 98.5 % to 100.5% |
| Propyl Gallate BP/EP | |
| Specification | For : Propyl Gallate B.P |
| Test | Specification |
| Description | White or almost white crystalline powder |
| Identification | A) Melting point : Limit :1480C
to 1510C C) TLC for Gallic Acid D) Chemical test |
| Solubility | Very slightly soluble in water, freely soluble in ethanol (96%). It dissolves in dilute solution of Alkali hydroxide. |
| Appearance of solution | 5% w/v solution of sample in alcohol is clear. |
| Gallic acid | Limit : Max. 0.5% |
| Chlorine | Limit : Max.200 PPM |
| Total Chloride | Limit : Max.100 PPM |
| Zinc (Atomic Absorption Spectrometry) | Limit : Max. 25 PPM |
| Heavy Metals | Limit : Max.10 PPM |
| Loss on drying | Limit: Max. 0.5% |
| Sulphated Ash | Limit : Max..0.1 % |
| Assay | Limit: 97% to 103% |
| Silver Sulphadiazine USP | |
| Specification | For : Silver Sulphadiazine U.S.P. |
| Test | Specification |
| Description | Fine white powder |
| Identification | A) I. R. Test passes B) T.L.C. Passes C) Passes |
| Chromatographic Purity | Sum of all secondary spots is Max. 2% |
| Nitrate | Limit: Max.0.1 % |
| Particle Size | Limit : Less than 10 microns |
| Loss on drying (At 105 0 C) | Limit ; Max. 0.5 % |
| Sulphadiazine Content | Limit : Around 70% |
| Silver Content | Limit : Between 29.3 % to 30.5 % |
| Assay | Limit:98% to 102% |
| (On Dried Basis) | |
| (By H.P.L.C.) | |
| Alendronate Sodium BP | |
| Specification | For : Sodium Alendronate BP or 4-Amino 1-Hydroxy Butylidene Bis Phosphonic Acid Mono Sodium Salt Tri Hydrate |
| Test | Specification |
| Description | White crystalline powder, Odourless, Tasteless |
| Identification | A) I. R. Test should complies with IR of standard. |
| Solubility | Soluble in water very slightly soluble in Methanol, practically insoluble in Methylene Chloride |
| Appearance of Solution | Clear and colour less solution |
| Heavy Metals | Limit: Max.20 PPM |
| Ph (1% Solution) | Limit between 4.0 to 5.0 (0.5 Gms in 50 ML Water) |
| 4 - Amino Butyric Acid (By TLC) | Limit: Max.0.5% |
| Phosphate and Phosphite (By H.P.L.C.) | Limit: Max.0.5% |
| Loss on drying (at 140° C to 145°C) | Limit: 16.1% to 17.1% |
| Assay (On Dried Basis) (By H.P.L.C.) (By Titration) |
Limit: 98% to 102% |
| Tizanidine HCl USP | |
| Specification | For : Tizanidine Hydrochloride U.S.P |
| Test | Specification |
| Description | A white to off white crystalline powder. |
| Solubility | Soluble in water and methanol, practically insoluble in acetone, chloroform, ethyl acetate. |
| Identification A) IR Spectrum |
IR absorption spectrum of sample in KBR dispersion is concordant with that of reference standard of Tizanidine HCl |
| B) HPLC | 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. |
| pH (A 1% w/v aqueous solution) | Limit between 4.3 to 5.3 |
| Loss On Drying (At 105 0 FOR 3 HRS) | NMT 0.5 % w/w |
| Residue on Ignition | NMT 0.1% w/w |
| Heavy Metals | Not more than 0.002% |
| Related Substance (HPLC) Tizanidine related compound C Tizanidine related compound B Tizanidine related compound A Individual unknown impurity Total impurities |
Not more than 0.1% Not more than 0.1% Not more than 0.1% Not more than 0.1% Not more than 0..3% |
| Organic volatile impurities | Meets the requirement |
| Content of Chloride | NLT 11.9% & NMT12.5% |
| Assay (By Titration) (On Dried Basis) | Limit: 98.0 % TO 102.0 % w/w |
| Risedronate Sodium | |
| Specification | For : Risedronate Sodium |
| Chemical Name | Sodium Salt of [1-Hydroxy-2-(3-pyridinyl)ethylidene] bisphosphonic acid |
| CAS No: | 115436-72-1 |
| Molecular Formula | C7H10NNaO7P2 |
| Molecular Weight | 305.11 |
| Merck Index No. | 8315 |
| Test | Specification |
| Description | White to off white Crystalline powder |
| Identification | A) I.R. absorption Spectrum |
| Solubility | Soluble (1%) in 0.1 M sodium hydroxide, Sparingly soluble in water, very slightly soluble in ethanol and in dimethyl formamide. |
| Clarity and colour of solution (1% w/v in 0.1N NaOH) | Clear and colourless |
| pH of a 1% in w/v solution in Water | Limit : 4.2 ? 5.2 |
| Loss on Drying | Limit : 11.5% - 13.5% |
| Heavy Metals | Limit : Max. 20 PPM |
| Related Substances a) Pyridine ? 3 acetic acid (by HPLC) b) Phosphite content (by titrimetry) |
Limit : Max. 0.25 Max..1.0 |
| Assay (by HPLC) (On anhydrous basis) | Limit : 98.0% to 102.0% |
| Trimetazidine HCl J.P. | |
| Specification | For : Trimetazidine HCl J.P. |
| Chemical Composition | C14H22N2O3.2HCl |
| Molecular wt. | 339.26 |
| Test | Specification |
| Description | A white Crystalline Powder, Slightly hygroscopic. |
| Solubility | Soluble in water, sparingly soluble in ethanol & practically insoluble in ether |
| Identification | A) Test Passes B) Test Passes |
| Heavy Metals | Limit: Max. 20 PPM |
| Arsenic | Limit :Max.2PPM |
| Ph of Solution ( 1 in 20) | Limit : 2.3 to 3.3 |
| Clarity And Colour of the Solution | Clear and Colourless Solution |
| Melting Point | Limit : 225o to 227o |
| Residue on Ignition | Limit : Max. 0.2 % |
| Loss on drying | Limit : Max.:2% |
| Assay | Limit: Min. 98% |
| Etidronate Disodium USP | |
| Specification | For : Etidronate Disodium USP |
| Test | Specification |
| Description | White crystalline powder |
| Identification A) By I.R. B) By Chemical |
I. R. Spectrum should be
concordant with reference standard. A solution (1 in 100) responds to flame test for sodium |
| Solubility (1% solution) | Soluble in water (carbon dioxide free) |
| pH (1% solution in water) | Limit : 4.2 to 5.2 |
| Water Content (By K.F.) | Limit: Max.5% |
| Phosphite | Limit : Max. 1% |
| Heavy Metals | Limit: Max.0.005% |
| Organic volatile Impurities | As per appendix (467), method 1 |
| Assay (By Titration) | Limit: 97 to 101% (On Dried Basis) |
| Ibandronate Sodium | |
| Specification | For : Ibandronate Sodium |
| Chemical Name | 1 Hydroxy 3(N ) Methly 3(N) n Pentylamino,1,1 Bisphosphonic Acid |
| Molecular Formula | C9H22O7NP2NaH2O |
| Molecular Weight | 359.17 |
| Test | Specification |
| Description | White crystalline powder |
| Solubility | Soluble in water, not soluble in alcohol |
| Loss on Drying | Limit : 4.5% - 8.5% |
| Chloride | Limit : Max. 0.005% |
| Sulphate | Limit : Max. 0.005% |
| Heavy Metals | Limit : Max. 0.001% |
| Related Substance | Limit : Max. 0.5% |
| Phosphite | Limit : Max. 0.3% |
| Assay (By HPLC) | Limit : Min. 99.5% |
| Fosphenytoin Sodium USP | |
| Specification | For : :Fosphenytoin Sodium USP |
| Test | Specification |
| Description | A white or almost white crystalline powder |
| Identification | A) IR B) The retention time of peak obtained in the chromatogram of the Assay preparation responds to that in the chromatogram of the standard preparation obtained in the test of assay C) Test for Sodium |
| pH | Limit : Between 8.5-9.5 |
| Water | Limit : Between 21.7%-25.7% |
| Heavy Metals | Limit : Max. 0.002% |
| Chromatographic Purity (BY HPLC) | Max. 0.1% of Phenytoin is found Max. 0.1% of the other impurity is found Max. 0.5% of the total impurities is found |
| Organic Volatile Impurities | Meets the requirements |
| Assay (BY HPLC) [on anhydrous basis] | Limit : 98% - 102% |
| Gabapentin | |
| Specification | For : Gabapentin |
| Test | Specification |
| Description | White to off white crystalline powder |
| Identification | |
| A) Test A | The IR spectrum of sample is concordant with the IR Spectrum of Gabapentin working std. Obtain in same manner |
| B) Test B | Retention time of the major peak in the chromatogram of assay Preparation corresponds to that in the chromatogram of the std. Preparation as obtained in the assay |
| Solubility | Soluble in water & 0.1N NaOH solution, sparingly soluble in methanol. |
| Residue on Ignition | Limit : Max. 0.1% w/w |
| Heavy Metals | Limit: Max.0.002 % w/w |
| Ph | Limit : between 6.5 to 7.5 |
| Chloride | Limit : Max. 0.01% w/w |
| Related Substances | |
| (By HPLC) | |
| a) Impurity at RRt about 0.5 | Limit : Max.0.1% |
| b) Gabapentin related compound A (Lactum) | Limit : Max.0.1% |
| c) Individual impurity | Limit : Max. 0.3% |
| d) Total impurity | Limit : Max.0.5% |
| Water Content | Limit: Max. 0.3% w/w |
| Organic Volatile Impurity & Residual Solvent | Acetone : Max. 5000µg/g Methanol : Max. 3000µg/g Methylene Chloride : Max. 600µg/g |
| Assay by HPLC (On dried Basis) | Limit: 99% to 101% w/w |
| Fluorescein Sodium USP | |
| Specification | For : Fluorescein Sodium USP |
| C. I. Name | Acid Yellow 73 |
| C.A.S. No. | 518-47-8 |
| C. I. No | 45350 |
| Test | Specification |
| Description | A Browinsh Orange powder. Al most odourless and hygroscopic in nature. |
| Absorption Maxima (Buffer = 8) ? max | Limit : 490-492 n m |
| Absorptivity (A1%,1 CM in Buffer = 8 at ? max ) | Limit : 2050-2200 |
| Solubility of 2 %Solution IN D.W. | Clear and Orange, Exhibits Yellowish Green Fluorescence |
| pH (2% Soltn IN D.W.pH=7) | Limit : 7 - 9 |
| Loss on Drying (AT 135 0 C For 1 HR.) | Limit : Max. 5 % |
| Chloride | Limit : Max. 1% |
| Sulphate | Limit : Max. 1 % |
| Sulphated ASH | Limit : 33.5-35 % |
| Zinc | Limit : Max. 0.1 % |
| Lead | Limit : 10 PPM |
| Arsenic | Limit : 3 PPM |
| Mercury | Limit : 1 PPM |
| Iron Grade | Not More Than 8 Small Iron Particles on Hand Magnet |
| Particle Size | 100 % Pass Through 100 Mesh Size |
| Pioglitazone HCl (In House) | |
| Specification | For : Pioglitazone HCI [In House] |
| Chemical Name | 5-[4-[2-(5-ethyl-2 pyridyl) ethoxy] benzyl] -2,4 thiazolidinedione hydrochloride |
| Test | Specification |
| Description | White to off white powder |
| Identification | A) IR Test should concordant with
IR of Standard. B) Gives Reaction of Chloride. |
| Solubility | Soluble in dimethyl formamide,
Slightly soluble in anhydrous Ethanol, very slightly soluble in Acetone and Acetonitrile, practically insoluble in ether and in water |
| Residue on Ignition | Limit: Max. 0.2% |
| Melting Point | Limit: 193-1960C |
| Heavy Metals | Limit: Max. 20 PPM |
| Loss on Drying (at 1050C, 3hr) | Limit: Max. 0.5%w/w |
| Related Substances (HPLC) Individual Impurity Total Impurity | Limit: Max. 0.5% Limit: Max. 1.0% |
| Assay (HPLC) (On Dried Basis) | Limit: 98.0%-101.5% |
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OUR PRODUCTS |
Active Pharma Ingredients | Pharma Intermediates | Under Developments |
|
PRODUCT SPECIFICATIONS |
Active Pharma Ingredients | Pharma Intermediates |
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