SPECIFICATION AS PER IP 2014

TESTS SPECIFICATIONS
Description Colourless crystals or a white, crystalline powder; odour, characteristic and somewhat camphoraceous; sublimes readily.
Solubility Freely soluble in ethanol (95%), in ether, in Chloroform and in volatile oils; slightly soluble in water.
Identification A, B, C: To Comply as per IP D: Melting Point Limit :About 77°C
Appearance of solution To Comply as per IP
Acidity NMT 0.1 ml of 0.1M NaOH
Chloride Max. 500 ppm
Sulphated Ash NMT 0.1%
Water Content Limit 4.5% to 6.0%
Assay : Content ofChlorbutol (C4 H7 Cl3 O) (Limit 98.0% to 101.0%) on anhydrous basis
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SPECIFICATION AS PER BP 2014

TESTS SPECIFICATIONS
Characters A white crystalline powder or colourless crystals, sublimes readily
Solubility slightly soluble in water, very soluble in ethanol 96%, soluble in glycerol 85°C.
Melting Point Limit : It melts at about 78°C determined without previous drying
Identification A, B, C, D : To Comply as per BP
Appearance of Solution 1) Clarity of Solution
2) Colour of Solution To Comply as per BP
Acidity NMT 1.0 ml of 0.01M NaOH
Chlorides NMT 100 ppm
Water Limit 4.5% to 5.5%
Sulphated Ash NMT 0.1%
Assay : Content ofChlorobutanol (C4 H7 Cl3 O) (Limit 98.0% to 101.0%) on anhydrous basis
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SPECIFICATION AS PER USP37/NF32

TESTS SPECIFICATIONS
Identification A: IR spectrum - Exhibit absorption maxima only at same wave numbers as that of USP Chlorobutanol RS (USP30-NF25) B: Chemical test - 0.5 % w/v aqueous solution on addition to 1 ml of 1 N sodium hydroxide. Add drop wise 3 ml of iodine TS. Yellow precipitate of iodoform produce and the precipitate has recognizable odor (USP30-NF25)
Reaction to litmus 2% w/v solution in water is neutral to litmus (USP30-NF25)
Water Not more than 6.0 % (USP30-NF25)
Chloride 0.07 % (USP30-NF25)
Assay Contains not less than 98.0 per cent and not more than 100.5 per cent calculated on anhydrous basis (USP30-NF25)
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SPECIFICATION AS PER USP37/NF32

TESTS SPECIFICATIONS
Identification A: IR spectrum - Exhibit absorption maxima only at same wave numbers as that of USP Chlorobutanol RS (USP30-NF25) B: Chemical test - 0.5 % w/v aqueous solution on addition to 1 ml of 1 N sodium hydroxide. Add drop wise 3 ml of iodine TS. Yellow precipitate of iodoform produce and the precipitate has recognizable odor (USP30-NF25)
Reaction to litmus 2% w/v solution in water is neutral to litmus (USP30-NF25)
Water Not more than 6.0 % (USP30-NF25)
Chloride 0.07 % (USP30-NF25)
Assay Contains not less than 98.0 per cent and not more than 100.5 per cent calculated on anhydrous basis (USP30-NF25)
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SPECIFICATION AS PER EP 2014

TESTS SPECIFICATIONS
Characters A white crystalline powder or colourless crystals, sublimes readily
Solubility slightly soluble in water, very soluble in ethanol 96%, soluble in glycerol 85°C.
Melting Point Limit : It melts at about 78°C determined without previous drying
Identification A, B, C, D : To Comply as per EP
Appearance of Solution 1) Clarity of Solution
2) Colour of Solution To Comply as per EP
Acidity NMT 1.0 ml of 0.01M NaOH
Chlorides NMT 100 ppm
Water Content 4.5% to 5.5%
Sulphated Ash NMT 0.1%
Assay : Content of Chlorobutanol(C4 H7 Cl3 O) 98.0% to 101.0% on anhydrous basis
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SPECIFICATION AS PER BP 2014

TESTS SPECIFICATIONS
Characters A white crystalline powder or colourless crystals, sublimes readily,
Solubility Slightly soluble in water, very soluble in ethanol 96%, soluble in glycerol 85°C
Melting Point It melts at about 95°C determined without previous drying
Identification A, B, C, D To Comply as per BP
Appearance of Solution To Comply as per BP
Acidity NMT 1.0 ml of 0.01M NaOH
Chlorides NMT 300 ppm
Water NMT 1.0% w/w
Sulphated Ash NMT 0.1%
Assay : Content ofChlorobutanol (C4 H7 Cl3 O) 98.0% to 101.0% on anhydrous basis
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SPECIFICATION AS PER IP 2014

TESTS SPECIFICATIONS
Description A white or Creamy white, crystalline powder; odourless or almost odourless
Solubility Freely soluble in ethanol 95% and in ether, very slightly soluble in water and in arachis oil
Identification A) To Comply as per IP
B) To Comply as per IP
C) To Comply as per IP
Melting Point 148 °C – 151 °C
Chlorides NMT 500 PPM
Sulphates NMT 0.12%
Sulphated Ash NMT 0.1%
Loss on drying NMT 1%
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SPECIFICATION AS PER BP 2014

TESTS SPECIFICATIONS
Characters A white or Creamy white, crystalline powder, very slightly soluble in water, freely soluble in ethanol (96%). It dissolves in dilute solutions of alkali hydroxides
Identification A) Range - 148°C - 151°C
C) To Comply As Per BP
D) To Comply As Per BP
Appearance of solution To Comply as per BP
Gallic Acid To Comply As Per BP
Total Chlorine NMT 200 PPM
Chlorides NMT 100 PPM
Zinc NMT 25 PPM
Heavy Metals (Pb) NMT 10 PPM
Loss on drying NMT 0.5%
Sulphated Ash NMT 0.1%
Assay: Contents of Propyl Gallate (C10H12O5) 97.0 % to 103.0 % on D. B.
D
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SPECIFICATION AS PER USP 37 /NF 32

TESTS SPECIFICATIONS
Identification A: IR absorption - Exhibit absorption bands only at same wave numbers as that of USP Propyl Gallate RS B: UV absorption - Exhibit absorption maxima and minima at same wavelengths as that of USP Propyl Gallate RS solution
Melting Range 146°C to 150°C
Loss on drying Not more than 0.5 %
Residue on ignition Not more than 0.1%
Heavy metals 0.001%
Assay Not less than 98.0 per cent and not more than 102.0 per cent of C10H12O5. Calculated on dried basis
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SPECIFICATION AS PER IP 2014

TESTS SPECIFICATIONS
Description White or almost White crystals or crystalline powder.
Solubility Soluble in water, Ethanol (95%), Ethyl acetate, Slightly soluble in Chloroform, Acetone, Ether and Benzene
Identification A. By Infrared absorption B. To Comply as per IP
Melting Point About 130° C
pH Between 5 to 7.0
Related substances To Comply as per IP (By HPLC)
Sulphated Ash NMT 0.1%
Water Content NMT 0.5% W/W
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SPECIFICATION AS PER BP 2014

TESTS SPECIFICATIONS
Description White or almost White crystals or crystalline powder.
Solubility Freely Soluble in water, Ethanol (96%), Slightly soluble in glycerol and in liquid paraffin
Identification A. By Infrared absorption B. To Comply as per BP
Melting Point About 130° C
pH Between 5 to 7.0
Related substances To Comply as per IP (By HPLC)
Sulphated Ash NMT 0.1%
Water Content NMT 0.5% w/w
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SPECIFICATION AS PER IP 2014

TESTS SPECIFICATIONS
Description Colourless crystals or white, crystalline powder.
Solubility Freely soluble in ethanol (95%), in ether and in methanol; very slightly soluble in water.
Identification A) To Comply as per IP (IR)
Melting Point 125 ° C to 128 ° C
Appearance of Solution To Comply as per IP
Acidity NMT 0.1ml of 0.1M NaOH
Related substances To Comply as per IP
Chloride NMT 500 PPM
Sulphates To Comply as per IP
Sulphated Ash Not more than 0.1%
Assay Not less than 98.0% and not more than to 102.0 % of C8H8O3
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SPECIFICATION AS PER BP 2014

TESTS SPECIFICATIONS
Appearance A white crystalline powder or colorless crystals.
Solubility Very slightly soluble in water, freely soluble in ethanol 96% and in methanol.
Identification A) MP (Lt. 125 ° C to 128 ° C)
B) To Comply as per BP (IR)
Appearance of Solution To Comply as per BP
Acidity NMT 0.1ml of 0.1M NaOH
Related substances To Comply as per BP (By HPLC)
Sulphated Ash NMT 0.1%
Assay : Contents of Methylparaben (C8 H8 O3) 98.0% to 102.0% calculated on D.B.
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SPECIFICATION AS PER USP 37/ NF 32 2014

TESTS SPECIFICATIONS
Identification A)To Comply
B) To Comply
Colour of solution To Comply
Acidity NMT 0.1ml of 0.1M NaOH
Residue on ignition NMT0.1%
Related substances To Comply (HPLC)
Assay: Contents of Methyl Paraben 98% to 102.0% of C8H8O3 on D.B.
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SPECIFICATION AS PER IP 2014

TESTS SPECIFICATIONS
Description A white crystalline powder; odourless.
Solubility Freely soluble in ethanol (95%), in acetone, in ether and in methanol, very slightly soluble in water.
Identification A) Light Absorption Test A
B) To Comply as per IP
Melting Point 96° C – 99° C
Appearance of solution To Comply as per IP
Acidity NMT 0.1ml of 0.1M NaOH
Related substances To Comply as per IP
Chloride NMT 500 ppm
Sulphates To Comply as per IP
Sulphated Ash NMT 0.1%
Loss on drying NMT 0.5%
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SPECIFICATION AS PER USP BP 2014

TESTS SPECIFICATIONS
TESTS

SPECIFICATIONS
Appearance A white crystalline powder.
Solubility Very slightly soluble in water, freely soluble in ethanol 96% and in methanol.
Identification A) MP (Lt. 96° C to 99° C)
B) To Comply as per BP (IR)
C) To Comply as per BP
Appearance of Solution To Comply as per BP
Acidity NMT 0.1ml of 0.1M NaOH
Related substances To Comply as per BP (By HPLC)
Sulphated Ash NMT 0.1%
Assay : Contents of Propyl Paraben (C10 H12 O3) 98.0% to 102.0% calculated on D.B.
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SPECIFICATION AS PER USP 37/ NF 32 2014

TESTS SPECIFICATIONS
Identification A)To Comply
B) To Comply
Colour of solution To Comply
Acidity NMT 0.1ml of 0.1N NaOH
Residue on ignition NMT0.1%
Related substances To Comply (HPLC)
Assay: Contents of Propyl Paraben 98% to 102.0% of C10H12O3 on D.B.
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SPECIFICATION AS PER IP 2014

TESTS SPECIFICATIONS
Description A white crystalline powder, odourless & Hygroscopic.
Solubility Freely soluble in water; sparingly soluble in ethanol (95%); practically insoluble in fixed oils.
Identification A) To Comply as per IP (IR)
B) To Comply as per IP
Appearance of Solution To Comply as per IP
pH (0.1% w/v soln.) Between 9.5 to 10.5
Related substances To Comply as per IP
Chlorides NMT 330 PPM
Sulphates NMT 0.12% w/w
Water Content NMT 5.0% w/w
Assay : Contents of Sodium Methyl Paraben (C8 H7 Na O3) 95% to 102.0% calculated on anhydrous basis
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SPECIFICATION AS PER BP 2014

TESTS SPECIFICATIONS
Characters A white crystalline powder, freely soluble in water, sparingly soluble in ethanol 96%, practically insoluble in methylene chloride.
Identification A) MP (Lt. 125 ° C to 128° C)
B) To Comply as per BP (IR)
C) To Comply as per BP
Appearance of Solution To Comply as per BP
pH Between 9.5 to 10.5
Related substances To Comply as per BP (By HPLC)
Chlorides NMT 350 PPM
Sulphates NMT 300 PPM
Heavy Metals (Pb) NMT 10 PPM (Pb)
Water Content NMT 5.0% w/w
Assay: Content of Sodium Methyl Paraben (C8H7NaO3) 95% to 102.0% calculated on anhydrous basis
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SPECIFICATION AS PER USP 37/ NF 32 2014

TESTS SPECIFICATIONS
Completeness of solution Appearance of both solutions is same
Identification To comply Identification A and B
pH Between 9.5 to 10.5
Water Content NMT 5.0% W/W
Chlorides 0.035%
Sulphates 0.12%
Assay: Content of Sodium Methyl Paraben (C8H7NaO3) 98.5% to 101.5% calculated on anhydrous basis
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SPECIFICATION AS PER IP 2014

TESTS SPECIFICATIONS
Description A white crystalline powder, odourless & Hygroscopic.
Solubility Freely soluble in water and in ethanol (50%): sparingly soluble in ethanol (95%); practically insoluble in fixed oils.
Identification A) To Comply as per IP (IR)
B) To Comply as per IP
pH (0.1% w/v soln.) Between 9.5 to 10.5
Related substances To Comply as per IP (HPLC)
Clarity of Solution To Comply as per IP
Chlorides NMT 330 PPM
Sulphates NMT 0.12% w/w
Water Content NMT 5.0% w/w
Assay : Contents of Sodium Propyl Paraben (C10 H11 Na O3) 94% to 102.0% calculated on anhydrous basis
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SPECIFICATION AS PER BP 2014

TESTS SPECIFICATIONS
Characters A white crystalline powder, hygroscopic, freely soluble in water, sparingly soluble in ethanol 96%, practically insoluble in methylene chloride
Identification A) MP: LT 96° C to 99° C
B) To Comply as per BP(IR)
D) To Comply as per BP
Appearance of Solution To Comply as per BP
pH Between 9.5 to 10.5
Related Substances To Comply as per BP (HPLC)
Chlorides NMT 350 PPM
Sulphates NMT 300 PPM
Heavy metals NMT 10 PPM
Water NMT 5.0% W/W
Assay: Contents of Sodium Propyl Paraben (C10 H11 Na O3) 94% to 102.0% calculated with reference to the anhydrous substance
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SPECIFICATION AS PER USP37/NF32 2014

TESTS SPECIFICATIONS
Completeness of solution Appearance of both solutions is same
Identification To comply Identification A and B
pH Between 9.5 to 10.5
Water Content NMT 5.0% W/W
Chlorides 0.035%
Sulphates 0.12%
Assay: Contents of Sodium Propyl Paraben (C10 H11 Na O3) 98.5% to 101.5% calculated with reference to the anhydrous substance
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SPECIFICATION AS PER IP 2014

TESTS SPECIFICATIONS
Appearance White or almost white, crystalline powder or colourless crystals.
Solubility Freely soluble in acetone, in ethanol (95%), in chloroform and in propylene glycol
Identification A)To Comply as per IP (IR)
Melting Point 68°C -71°C
Appearance of solution To Comply as per IP
Acidity NMT 0.1ml of 0.1M NaOH
Related substances To Comply as per IP (HPLC)
Sulphated Ash NMT 0.1%
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SPECIFICATION AS PER BP 2014

TESTS SPECIFICATIONS
Appearance White or almost white, crystalline powder or colourless crystals.
Solubility Very slightly soluble in water, freely soluble in ethanol 96% and in methanol.
Identification A)To Comply as per IP (MP)
B) To Comply as per IP (IR)
C) To Comply as per IP
Appearance of solution To Comply as per IP
Acidity NMT 0.1ml of 0.1M NaOH
Related substances To Comply as per IP (HPLC)
Sulphated Ash NMT 0.1%
Assay: Contents of Butyl Paraben 98% to 102.0% of C11H14O3 on D.B.
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SPECIFICATION AS PER USP37/NF32

TESTS SPECIFICATIONS
Identification A)To Comply
B) To Comply
Colour of solution To Comply
Acidity NMT 0.1ml of 0.1N NaOH
Residue on ignition NMT0.1%
Related substances To Comply (HPLC)
Assay: Contents of Butyl Paraben 98% to 102.0% of C11H14O3 on D.B.
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SPECIFICATION AS PER IP 2014

TESTS SPECIFICATIONS
Description A white crystalline powder or Colourless crystals
Solubility Freely soluble in ethanol (95%), very slightly soluble in water.
Identification A) To Comply as per IP (IR)
Appearance of Solution To Comply as per IP
Acidity NMT 0.1ml of 0.1M NaOH
Related substances(HPLC) To Comply as per IP
Sulphated Ash NMT 0.1%
Assay : Contents of Ethyl Paraben (C9 H10 O3) NLT 98% NMT 102%
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SPECIFICATION AS PER BP 2014

TESTS SPECIFICATIONS
Appearance White or almost white, crystalline powder or colourless crystals.
Solubility Very slightly soluble in water, freely soluble in alcohol and in methanol.
Identification A) Melting point-115°C to 118°C (BP2008)
B) IR spectrum exhibit maxima only at same wave numbers as that of Ethyl parahydroxybenzoate CRS
C) Thin layer chromatography-To comply as per BP
Appearance of Solution Colour of 10%w/v solution in alcohol is not more intensely coloured than reference solution BY6
Acidity For 2 ml 10%w/v solution in alcohol, not more than 0.1 ml of 0.1 M sodium hydroxide require to change colour of indicator to blue
Related substances To Comply as per BP
Sulphated ash Maximum 0.1 %
Assay Contain not less than 98.0 per cent and not more than 102.0 per cent of C9H10O3
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SPECIFICATION AS PER USP37/NF32

TESTS SPECIFICATIONS
Identification A: IR spectrum - Exhibit absorption maxima only at same wave numbers as that of USP Ethylparaben RS
B: Melting range - 115°C to 118°C
Color of solution Solution is clear and not more intensely colored than alcohol or Reference solution.
Acidity Not more than 0.1 ml of 0.10 N sodium hydroxide require to change color of solution to blue
Residue on ignition Not more than 0.1%
Related substances To Comply as per USP.
Assay Contain not less than 98.0 per cent and not more than 102.0 per cent of C9H10O3
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SPECIFICATION AS PER IP 2014

TESTS SPECIFICATIONS
Identification A, B and C To comply
Acidity NMT 3.0 ml of 0.01M NaOH required for colour change
Defoaming activity NMT 15 seconds
Heavy Metals 10 ppm
Assay Polydimethylsiloxane- 90.0%- 99.0% Silicon dioxide – 4.0%- 7.0%
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SPECIFICATION AS PER BP 2014

TESTS SPECIFICATIONS
Identification A, B and C To comply
Acidity NMT 3.0 ml of 0.01M NaOH required for colour change
Defoaming activity NMT 15 seconds
Mineral oils To comply
Phenylated compounds Absorbance Not greater than 0.2
Heavy Metals 5 ppm
Volatile matter NMT 1.0%
Assay Polydimethylsiloxane- 90.5%- 99.0% Silicon dioxide – 4.0%- 7.0%
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SPECIFICATION AS PER USP37/NF32

TESTS SPECIFICATIONS
Identification To comply
Loss on Heating NMT 18% by weight
Defoaming activity NMT 15 seconds
Heavy Metals 5 ppm
Assay Polydimethylsiloxane- 90.5%- 99.0% Silicon dioxide – 4.0% - 7.0%
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SPECIFICATION AS PER USP 37

TESTS SPECIFICATIONS
Identification To comply
Microbial Limits NMT 100 cfu/g
Defoaming activity NMT 15 seconds
Heavy Metals 5 ppm
Assay Polydimethylsiloxane- 25.5%- 33.0%
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Request for MSDS

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  • 1
  • CHLORBUTOL (HEMIHYDRATE) IP /BP/USP-NF/EP
    Description

    Category: Chlorbutol is a pharmaceutical aid (Antimicrobial preservative) analgesic, local anesthetic Chlorbutol is a 1,1.1-trichloro 2-methyl propan -2-ol hemihydrate. Chlorbutol contains not less than 98% and not more than 101% C4H7Cl3O Calculated on the anhydrous basis.

  • 3
  • CHLOROBUTANOL (ANHYDROUS)  BP/USP
    Description

    Category: Chlorobutanol Anhydrous is pharmaceutical aid(Local anesthetic, antimicrobial preservative) Chlorobutanol Anhydrous contains not less than 98% and not more than 101% of C4H7Cl3O. Chlorbutanol is a 1,1.1-trichloro 2-methyl propan -2-ol Calculated on the anhydrous basis. .

  • 5
  • DOCUSATE SODIUM  IP/BP/EP/USP
    Description

    Category: Docusate Sodium is a pharmaceutical aid(Laxative). Docusate Sodium is 1,4-Bis(2-Ethylhexyl) Sodium Sulfosuccinate. Docusate Sodium contains not less than 98.0 % and not more than 101.0 % of C20H37NaO7S, Calculated on an anhydrous basis.

  • 7
  • DOCUSATE SODIUM 85% POWDER IN-HOUSE  /USP
    Description

    Category: Docusate Sodium 85% Powder is a pharmaceutical aid (Laxative). Docusate Sodium 85% Powder is Dioctyl Sodium Sulfosuccinate Powder 85%. Sodium 85% Powder Contain not less than 83.0 % and not more than 87.0% w/w of C20H37NaO7S, calculated on anhydrous basis.8H8O3 .

  • 9
  • PROPYL GALLATE  IP/BP/USP
    Description

    Category: : Propyl Gallate is pharmaceutical aid (Antioxidant). Propyl Gallate is Benzoic acid, 3,4,5-trihydroxy-, propyl ester. Propyl gallate contains not less than 97.0 per cent and not more than the equivalent of 103.0 per cent of propyl 3,4,5-trihydroxybenzoate (C10H12O5) calculated with reference to the dried substance.

  • 2
  • METHYL PARABEN  IP/BP/USP-NF
    Description

    Category: Methyl Paraben is a pharmaceutical aid (Antimicrobial preservative) Methyl Paraben is methyl-4-hydroxybenzoate Methyl Paraben contains not less than 98% and not more than 102% C8H8O3 .



  • 4
  • SODIUM METHYL PARABEN  IP/BP/USP-NF
    Description

    Category: Sodium Methyl Paraben is a pharmaceutical aid (Antimicrobial preservative) Sodium methyl Paraben is a sodium salt of methyl-4-hydroxy benzoate Sodium methyl Paraben contains not less than 98% and not more than 102% C8H7NaO Calculate on the anhydrous basis.

  • 6
  • BRONOPOL  IP/BP
    Description

    Category: Bronopol is pharmaceutical aid (Antimicrobial Preservative). Bronopol is 1,3- Propanediol,2-bromo-2-nitro. Bronopol contains not less than 99.0% and not more than 101.0% of C3H6BrNO4 calculated on anhydrous basis

  • 8
  • PROPYL PARABEN  IP/BP/USP- NF
    Description

    Category: Propyl Paraben is a pharmaceutical aid (Antimicrobial preservative) Propyl Paraben is propyl-4-hydroxy benzoate Paraben contains not less than 98% and not more than 102% C10H12O3 Calculate on the dried basis.



  • 10
  • SODIUM PROPYL PARABEN  IP/BP/USP-NF
    Description

    Category: Sodium Propyl Paraben is a pharmaceutical aid (Antimicrobial preservative) Sodium Propyl Paraben is a sodium salt of propyl-4-hydroxy benzoate Sodium Propyl Paraben contains not less than 94% and not more than 102% C10H11NaO3 Calculate on the anhydrous basis.

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