Factors of Raw Material (Active)

Here is the list of factors for some raw material in B.P and U.S.P. By using these factors you can remove unwanted chemical groups from active and effective one. According to your label claim and raw material. I explain, let one has Lincomycin HCl and label claim for drug is only lincomycin then one should remove the HCl group or in other words, He should add so much quantity to manufacture a batch that the active Lincomycin should gave 100% assay when compared to B.P or U.S.P. Reference standard Lincomycin. For that reason here is the list of Raw Material factors that should be multiplied with the required quantity of raw material to fulfill the requirements of active present in raw material.
Sr. NoProduct NameMolecular WeightFactor
1Atorvastatin Calcium Trihydrate 1209.421.0843
Atorvastatin1115.34
2Azithromycin Dihydrate7851.0481
Azithromycin749
3Ciprofloxacin HCl Monohydrate 385.521.1646
Ciprofloxacin331.02
4Cetirizine Dihydrochloride 461.821.1878
Cetirizine370.38
5Cefixime Trihydrate 507.51.1192
Cefixime453.45
6Calcium Acetate 158.663.9479
Calcium40.07
7Cephradine Monohydrate 367.431.0516
Cephradine349.41
8Escitalopram Oxalate414.41.2774
Escitalopram324.39
9Esomeprazole Mg.Trihydrate 762.21.1137
Esomeprazole713.1
10Iron III Hydroxide Polymaltos Complex449.163.04
Elemental Iron147.75
11Levofloxacin Hemihydrate 370.381.0249
Levofloxacin 361.38
12Montelukast Sodium 608.171.0392
Montelukast 585.17
13Naproxen Sodium252.231.1003
Naproxen 229.23
14Pantoprazole Sodium Sesquihydrate432.41.1306
Pantoprazole382.4
15Lincomycin HCl461.011.134
Lincomycin406.51
16Gentamicin Sulphate Nlt 590 µg/mg1.6949
Gentamicin1000 µg/mg
17Thiamine HCl 337.31.1213
Thiamine300.8
18Pyridoxine HCl 205.61.2158
Pyridoxine 169.1
 

Gentamicin Sulfate

Gentamicin Sulfate

ABOUT:

Gentamicin Sulfate is the sulfate of a mixture of aminoglycoside substances having antibacterial activity produced by the growth of Micromonospora purpurea or Micromonospora echinospora.

PHYSICAL APPEARANCE:

Gentamicin Sulfate occurs as a white to light yellowish white powder. It is highly hygroscopic.

CHEMICAL FORMULA:

C21H43N5O7. xH2SO4 CHEMICAL STRUCTURE:
Gentamicin Sulfate
Gentamicin Sulfate

MOLECULAR WEIGHT:

477.60

IUPAC NAME:

(6R)-2-Amino-2,3,4,6-tetradeoxy-6-methylamino-6-methyl-α-D-erythrohexopyranosyl-(1→4)-[3-deoxy-4-C-methyl-3-methylamino-β-L-arabinopyranosyl-(1→6)]-2-deoxy-Dstreptamine sulfate

CONTENTS:

It contains not less than 590 mg (potency) and not more than 775 mg (potency) per mg, calculated on the dried basis. The potency of Gentamicin Sulfate is expressed as mass (potency) of gentamicin C1

SOLUBILITY:

  • Soluble in water.
  • Typically insoluble in ethanol. (96%)

IDENTIFICATION BY PPT. FORMATION:

Dissolve 50 mg of Gentamicin Sulfate in 5 mL of water, and add 0.5 mL of barium chloride TS: a white precipitate is formed.

COLOR OF SOLUTION:

Dissolve 1.0g of Gentamicin Sulfate in 10 mL of water, the solution is clear and colorless to pale yellow.

IDENTIFICATION BY THIN LAYER CHROMATOGRAPHY:

Dissolve 50 mg each of Gentamicin Sulfate and Gentamicin Sulfate Reference Standard in 10 mL of water, and use both of these solutions as the sample solution and standard solution. Perform the test with these solutions as directed under thin layer-Chromatography. Spot 20 µL of the sample solution and standard solution on a plate of silica gel for thin layer-Chromatography. Separately, shake a mixture of chloroform, ammonia solution and methanol in ration of (2:1:1) in a separator, and allow the mixture to stand for more than 1 hour. To 20 mL of the lower layer so obtained add 0.5 mL of methanol, and use this as the developing solvent. Develop the plate with the developing solvent to a distance of about 17cm in a developing container with a cover, having an opening of about 20 mm2, and without putting a filter paper in the container, and air-dry the plate. Allow the plate to stand in iodine vapors: three principal spots obtained from the sample solution are the same with the corresponding spots obtained from the standard solution in color tone and the Rf value, respectively.

pH:

The pH of a solution obtained by dissolving 400 mg of Gentamicin Sulfate in 10 mL of water is between 3.5 and 5.5

LOSS ON DRYING:

Not more than 18.0% when 0.15g of Gentamicin Sulfate at pressure not exceeding 0.67 kPa and temperature 110°C for 3 hours. Handle the sample avoiding absorption of moisture.

RESIDUE ON IGNITION:

Should be not more than 1.0% when 1.0 gram is ignited.

SPECIFIC OPTICAL ROTATION:

+107°   to   +121° When 100mg of Gentamicin Sulfate is dissolved in 10ml of water.

QUANTITATIVE ASSAY (BIO-ASSAY):

Perform the test according to the Cylinder-plate method as directed under Microbial Assay for Antibiotics according to the following conditions. Test organism Staphylococcus epidermidis ATCC Agar media for seed and base layer
  • Glucose 1.0 g
  • Peptone 6.0 g
  • Meat extract 1.5 g
  • Yeast extract 3.0 g
  • Sodium chloride 10.0 g
  • Agar 15.0 g
  • Water 1000 mL
Mix all the ingredients, and sterilize. Adjust the pH of the solution so that it will be 7.8 to 8.0 after sterilization. Agar medium for transferring test organisms. Use the medium Agar media for seed and base layer in Medium for other organisms under Agar media for transferring test organisms. Standard solutions Weigh accurately an amount of Gentamicin Sulfate Reference Standard, equivalent to about 25 mg (potency), dissolve in 0.1 mol/L phosphate buffer solution (pH 8.0) to make exactly 25 mL, and use this solution as the standard stock solution. Keep the standard stock solution at 15°C or lower, and use within 30 days. Take exactly a suitable amount of the standard stock solution before use, add 0.1 mol/L phosphate buffer solution (pH 8.0) to make solutions so that each mL contains 4 mg (potency) and 1 mg (potency), and use these solutions as the high concentration standard solution and the low concentration standard solution, respectively. Sample solutions Weigh accurately an amount of Gentamicin Sulfate, equivalent to about 25 mg (potency), and dissolve in 0.1 mol/L phosphate buffer solution (pH 8.0) to make exactly 25 mL. Take exactly a suitable amount of this solution, add 0.1 mol/L phosphate buffer solution (pH 8.0) to make solutions so that each mL contains 4 mg (potency) and 1 mg (potency), and use these solutions as the high concentration sample solution and the low concentration sample solution, respectively.

STORAGE CONDITIONS:

It should be stored in tight and air-free containers and should be keep away from moisture area.

REFERENCES:

Japan Pharmacopia (JP XVII) Official monographs Page 983. United State Pharmacopia (USP 41) Page 938.

Tranexamic Acid

Tranexamic Acid

Physical Appearance :

Tranexamic Acid occurs as white, crystals or crystalline powder. It belongs to antifibrinolytic family. Tranexamic Acid, when dried, contains not less than 98.0% and not more than 101.0% of tranexamic acid (C8H15NO2)

Structural formula:

 
Tranexamic Acid
Tranexamic Acid

Chemical Formula

(C8H15NO2).

Solubility:

It is freely soluble in water, and practically insoluble in ethanol (99.5).

Identification : BY FTIR

Determine the infrared absorption spectrum of Tranexamic Acid as directed in the potassium bromide disk method under Infrared Spectrophotometry, and compare the spectrum with the Reference Spectrum or the spectrum of Tranexamic Acid RS: both spectra exhibit similar intensities of absorption at the same wave numbers.

pH:

The pH of a solution prepared by dissolving 1.0 g of Tranexamic Acid in 20 mL of water is between 7.0 and 8.0.

Color of solution:

Dissolve 1.0 g of Tranexamic Acid in 10 mL of water: the solution is clear and colorless.

LOD: (LOSS ON DRYING)

Not more than 0.5% (1 g, for 2 hours).

Residue on ignition :

Not more than 0.1%

ASSAY : ( HPLC-Method)

Mobile Phase:

Dissolve 11.0 g of anhydrous sodium dihydrogen phosphate in 500 mL of water, and add 5 mL of triethylamine and 1.4 g of sodium lauryl sulfate. Adjust the pH to 2.5 with phosphoric acid or diluted phosphoric acid (1 in 10), add water to make 600 mL, and add 400 mL of methanol. Standard Preparation: Weigh accurately about 50 mg of Tranexamic Acid RS, previously dried, dissolve in water to make exactly 25 mL, and use this solution as the standard solution.

Sample Preparation:

Weigh accurately about 50 mg of Tranexamic Acid, previously dried, dissolve in water to make exactly 25 mL, and use this solution as the sample solution.

Chromatographic conditions:

Sample Volume: 20µL Detector: UV ʎmax=220nm Column: A stainless steel column 6.0 mm in inside diameter and 25 cm in length, packed with octadecylsilanized silica gel for liquid chromatography (5 mm in particle diameter). Column temperature: 25°C Flow rate: Adjust so that the retention time of tranexamic acid is about 20 minutes.

Calculations:

Contents of Tranexamic acid can be calculated by given formula %age Assay =   Hs/Ha × Ca/Cs × 100 Hs = Peak height ratio from the Sample solution Ha = peak height ratio from the Standard solution Ca = concentration of Alclometasone Dipropionate in the Standard solution (mg/ml) Cs = concentration of the Sample solution (mg/ml)

Assay: (BY TITRATION) (non-aqueous )

Weigh accurately 10mg of tranexamic acid in a round 250ml conical flask and add 50ml of glacial acetic acid. Dissolve in magnetic stirrer. Now simply titrate it 0.1M perchloric acid. Each ml of 0.1M perchloric acid is equivalent to 15.72 mg of tranexamic acid.

Calculation:

Contents of Tranexamic acid can be calculated by given formula %age of tranexamic acid = (volume of 0.1M perchloric acid × 15.72) ÷ weight of sample taken.

ALTERNATIVE METHOD:(BY UV/vis Spectrophotometer)

STANDARD PREPARATION:

Weigh accurately about 50mg of Tranexamic acid of working standard in to 50ml volumetric flask and dilute it with distilled water. Take 1ml of this solution and dilute upto 100ml with the same solvent. SAMPLE PREPARATION: Weigh accurately about 50mg of Tranexamic acid of sample in to 50ml volumetric flask and dilute it with distilled water. Take 1ml of this solution and dilute upto 100ml with the same solvent. Take Reading at 210nm Contents of Tranexamic acid can be calculated by given formula %age of tranexamic acid= At/As × Cs/Ct × 100 At =  Absorbance Of  Tranexamic acid in Sample Solution. As =  Absorbance Of  Tranexamic acid in Standard Solution. Cs =  Concentration of standard solution (mg/ml) Ct =  Concentration of sample solution (mg/ml)

Alclometasone Dipropionate

Alclometasone dipropionate
Alclometasone dipropionate is a synthetic glucocorticoid corticosteroid and a corticosteroid ester. At is an Active raw material for different products in pharmaceutical industry. CHEMICAL FORMULA C23H37ClO7 CHEMICAL STRUCTURE
Alclometasone dipropionate
Alclometasone dipropionate
DEFINITION Alclometasone Dipropionate contains not less than 97.0% and not more than 102.0% of C23H37ClO7 calculated on the dried basis. ASSAY (HPLC PROCEDURE) MOBILE PHASE: Methanol and Solution A in ratio (2: 1) SOLUTION A: 6.80 mg/ml of monobasic potassium phosphate (0.05 M) INTERNAL STANDARD SOLUTION: 2 mg/ml of betamethasone dipropionate in methanol STANDARD STOCK SOLUTION: 1.2 mg/ml of Alclometasone Dipropionate reference standard in methanol STANDARD SOLUTION: 4.0 ml of Standard stock solution and 4.0 ml of Internal standard solution. Dilute with methanol to 25 ml. ( this solution contains 0.2 mg/ml of Alclometasone Dipropionate reference standard.) SAMPLE STOCK SOLUTION: 1.2 mg/ml of Alclometasone Dipropionate in methanol SAMPLE SOLUTION: 4 ml of Sample stock solution and 4 ml of Internal standard solution. Dilute with methanol to 25 ml. CHROMATOGRAPHIC SYSTEM Mode: LC Detector: UV 254 nm Column: 4-mm x 30-cm; packing L 1 Flow rate: 1.2 ml/min Injection size: 10 µL  RELATIVE STANDARD DEVIATION Relative Standard Deviation should not be more than 2%. CALCULATION %age Assay =   Hs/Ha × Ca/Cs × 100 Hs = Peak height ratio from the Sample solution Ha = peak height ratio from the Standard solution Ca = concentration of Alclometasone Dipropionate in the Standard solution (mg/ml) Cs = concentration of the Sample solution (mg/ml) ACCEPTANCE CRITERIA: 97.0%  -  102.0% on the dried basis IMPURITIES
  • INORGANIC
RESIDUE ON IGNITION: Should be Not More Than 0.1%. HEAVY METALS: Should be Not More Than 30ppm.
  • Organic
HPLC-PROCEDURE MOBILE PHASE: Acetonitrile and water (3:2) DILUENT: Acetonitrile and water (2:1) SYSTEM SUITABILITY SOLUTION: 1.5 mg/ml of Alclometasone Dipropionate reference standard and 0.015 mg/ml of Alclometasone Dipropionate Related Compound in Diluent SAMPLE SOLUTION: 1.5 mg/ml of Alclometasone Dipropionate in Diluent CHROMATOGRAPHIC SYSTEM Mode: LC Detector : UV 254 nm Column: 4.6-mm x 15-cm; 5 µm packing L1 Flow rate: 1 ml/min Injection size: 5 µL Run time: Three times the retention time of alclometasone Tailing factor: NMT 1.5 for alclometasone dipropionate Relative standard deviation: NMT 2.0% for alclometasone dipropionate Resolution: NLT 2.0 between alclometasone dipropionate and alclometasone dipropionate related compound A CALCULATION Ai/Aa × 1/F × 100 Ai = Peak area for each impurity from the sample solution Aa = Sum of all peaks from sample solution F = Relative response factor ACCEPTANCE CRITERIA: Total impurities should be not more than 2.0%. SPECIFIC TESTS
  • OPTICAL ROTATION :
Sample solution: 30 mg/ml in dioxane Acceptance criteria: +21°  to  +25°
  • Loss on Drying: Dry a sample in a vacuum at a pressure not exceeding 5 mm of mercury at 105° for 3 h:
It loses NMT 0.5% of 1ts weight.