Petroleum Jelly or Petrolatum

Petroleum jelly or petrolatum or white petrolatum or soft paraffin or multi-hydrocarbon, is a semi-solid mixture of hydrocarbons, originally promoted as a topical ointment for its healing properties. Petroleum jelly’s benefits come from its main ingredient petroleum, which helps seal your skin with a water-protective barrier. It is recognized by the U.S. A. Food and Drug Administration as an approved over-the-counter (OTC) skin protectant and remains widely used in cosmetic skin care. Most uses of petroleum jelly exploit its lubricating and coating properties, including use on dry lips and dry skin.

Specifications of White Petrolatum USP & NF Grade:

DEFINITION
White Petrolatum is a purified mixture of semisolid hydrocarbons obtained from petroleum, and wholly or nearly decolorized. It may contain a suitable stabilizer.

Residue on Ignition:
Sample: 2 g
Analysis: Heat the Sample in an open porcelain or platinum dish over a flame.
Acceptance criteria: It volatilizes without emitting an acrid odor and yields NMT 0.05% of residue.
Procedure: Organic Acids:
Sample solution: 20.0 g of White Petrolatum in 100 mL of a 1 in 2 mixture of neutralized alcohol and water. Agitate thoroughly and heat to boiling.
Analysis: Add 1 mL of phenolphthalein and titrate rapidly with 0.1 N sodium hydroxide, with vigorous agitation to the production of a sharp pink endpoint, noting the color change in the alcohol–water layer.
Acceptance criteria: NMT 400 microL of 0.1 N sodium hydroxide is required.
Color: To pass the test.
Specific Gravity: 0.815–0.880 at 60C
Melting Range or Temperature:38C –60C
Consistency: To pass the test.
Alkalinity:
Sample: 35 g
Analysis: Introduce the Sample into a suitable beaker, add 100 mL of boiling water, cover, and place on a stirring hot-plate maintained at the boiling point of water. After 5 min, allow the phases to separate. Draw off the separated water into a casserole, wash the petrolatum further with two 50-mL portions of boiling water, and add the washings to the casserole. To the pooled washings, add 1 drop of phenolphthalein, and boil.
Acceptance criteria: The solution does not acquire a pink color.
Acidity:
Sample: Final solution of the test for Alkalinity, if the addition of phenolphthalein produced no pink color
Analysis: To the Sample, add 0.1 mL of methyl orange.
Acceptance criteria: No red or pink color is produced.
Fixed Oils, Fats, and Rosin:
Sample: 10 g
Analysis: Digest the Sample with 50 mL of 5 N sodium hydroxide at 100° for 30 min. Separate the water layer, and acidify it with 5 N sulfuric acid.
Acceptance criteria: No oily or solid matter separates.
Packaging and Storage: Preserve in well-closed containers.
Labeling: Label it to indicate the name and proportion of any added stabilizer.

Specifications of Petrolatum USP & NF Grade:

DEFINITION
Petrolatum is a purified mixture of semisolid hydrocarbons obtained from petroleum. It may contain a suitable stabilizer.

Residue on Ignition:
Sample: 2 g
Analysis: Heat the Sample in an open porcelain or platinum dish over a Bunsen flame.
Acceptance criteria: It volatilizes without emitting an acrid odor and yields NMT 0.1% of residue.
Procedure: Organic Acids:
Sample solution: 20.0 g of Petrolatum in 100 mL of a 1 in 2 mixture of neutralized alcohol and water. Agitate thoroughly, and heat to boiling.
Analysis: Add 1 mL of phenolphthalein, and titrate rapidly with 0.1 N sodium hydroxide, with vigorous agitation to the production of a sharp pink endpoint, noting the color change in the alcohol–water layer.
Acceptance criteria:  NMT 400 microL of 0.1 N sodium hydroxide is required.
Color: To pass the test.
Specific Gravity: 0.815–0.880 at 60C
Melting Range or Temperature: 38C –60C
Consistency: To pass the test.
Alkalinity:
Sample: 35 g
Analysis: Introduce the Sample into a suitable beaker, add 100 mL of boiling water, cover, and place on a stirring hot plate maintained at the boiling point of water. After 5 min, allow the phases to separate. Draw off the separated water into a casserole, wash the petrolatum further with two 50-mL portions of boiling water, and add the washings to the casserole. To the pooled washings, add 1 drop of phenolphthalein, and boil.
Acceptance criteria: The solution does not acquire a pink color.
Acidity: If the addition of phenolphthalein in the test for Alkalinity produces no pink color, add 0.1 mL of methyl orange.
Acceptance criteria: No red or pink color is produced.
Fixed Oils, Fats, and Rosin:
Sample: 10 g
Analysis: Digest the Sample with 50 mL of 5 N sodium hydroxide at 100° for 30 min. Separate the water layer, and acidify it with 5 N sulfuric acid.
Acceptance criteria: No oily or solid matter separates.
Packaging and Storage: Preserve in well-closed containers.
Labeling: Label it to indicate the name and proportion of any added stabilizer.

Specifications of White Soft Paraffin BP Ph Eur Grade:
White Petroleum Jelly

DEFINITION
Purified and wholly or nearly decolorised mixture of semi-solid hydrocarbons, obtained from petroleum. It may contain a suitable antioxidant. White soft paraffin described in this monograph is not suitable for oral use.

CHARACTERS
Appearance: White or almost white, translucent, soft unctuous mass, slightly fluorescent in daylight when melted.
Solubility: Practically insoluble in water, slightly soluble in methylene chloride, practically insoluble in ethanol (96 per cent) and in glycerol.

IDENTIFICATION
First identification: A, B, D
Second identification: A, C, D
A. The drop point is between 35C and 70C and does not differ by more than 5C from the value stated on the label, according to method with the following modification to fill the cup: heat the substance to be examined at a temperature not exceeding 80C, with stirring to ensure uniformity. Warm the metal cup at a temperature not exceeding 80C in an oven, remove it from the oven, place on a clean plate or ceramic tile and pour a sufficient quantity of the melted sample into the cup to fill it completely. Allow the filled cup to cool for 30 min on the plate or the ceramic tile and place it in a water bath at 24-26C for 30-40 min. Level the surface of the sample with a single stroke of a knife or razor blade, avoiding compression of the sample.
B. Infrared absorption spectrophotometry.
Preparation Place about 2 mg on a sodium chloride plate, spread the substance with another sodium chloride plate and remove 1 of the plates.
Comparison Repeat the operations using white soft paraffin CRS.
C. Melt 2 g and when a homogeneous phase is obtained, add 2 mL of water and 0.2 mL of 0.05 M iodine. Shake. Allow to cool. The solid upper layer is violet-pink or brown.
D. Appearance.

TESTS
Appearance: The substance is white. Melt 12 g on a water-bath. The melted mass is not more intensely coloured than a mixture of 1 volume of yellow primary solution and 9 volumes of a 10 g/L solution of hydrochloric acid.
Acidity or alkalinity: To 10 g add 20 mL of boiling water and shake vigorously for 1 min. Allow to cool and decant. To 10 mL of the aqueous layer add 0.1 mL of phenolphthalein solution. The solution is colourless. Not more than 0.5 mL of 0.01 M sodium hydroxide is required to change the colour of the indicator to red.
Consistency: 60 to 300.
Polycyclic aromatic hydrocarbons: To pass the test.
Sulfated ash: Maximum 0.05 per cent, determined on 2.0 g.

STORAGE
Protected from light.

LABELLING
The label states the nominal drop point.

Specifications of Yellow Soft Paraffin BP Ph Eur Grade:
Yellow Petroleum Jelly
Action and use: Excipient.

DEFINITION
Purified mixture of semi-solid hydrocarbons, obtained from petroleum. It may contain a suitable antioxidant.

CHARACTERS
Appearance: Yellow, translucent, unctuous mass, slightly fluorescent in daylight when melted.
Solubility: Practically insoluble in water, slightly soluble in methylene chloride, practically insoluble in ethanol (96 per cent) and in glycerol.

IDENTIFICATION
First identification: A, B, D
Second identification: A, C, D
A. The drop point is 40C to 60C and does not differ by more than 5C from the value stated on the label, with the following modification to fill the cup: heat the substance to be examined at 118-122C, with stirring to ensure uniformity, then cool to 100-107 °C. Warm the metal cup at 103-107 °C in an oven, remove it from the oven, place on a clean plate or ceramic tile and pour a sufficient quantity of the melted sample into the cup to fill it completely. Allow the filled cup to cool for 30 min on the ceramic tile and place it in a water-bath at 24-26C for a further 30-40 min. Level the surface of the sample with a single stroke of a knife or razor blade, avoiding compression of the sample.
B. Examine by infrared absorption spectrophotometry.
Preparation Place about 2 mg on a sodium chloride plate, spread the substance with another sodium chloride plate and remove 1 of the plates.
Comparison Repeat the operations using yellow soft paraffin CRS.
C. Melt 2 g and when a homogeneous phase is obtained, add 2 mL of water and 0.2 mL of 0.05 M iodine. Shake. Allow to cool. The solid upper layer is violet-pink or brown.
D. Appearance.

TESTS
Appearance: The substance is yellow. Melt 12 g on a water-bath. The melted mass is not more intensely coloured than a mixture of 7.6 volumes of yellow primary solution and 2.4 volumes of red primary solution.
Acidity or alkalinity: To 10 g add 20 mL of boiling water and shake vigorously for 1 min. Allow to cool and decant. To 10 mL of the aqueous layer add 0.1 mL of phenolphthalein solution. The solution is colourless. Not more than 0.5 mL of 0.01 M sodium hydroxide is required to change the colour of the indicator to red.
Consistency: 100 to 300.
Polycyclic aromatic hydrocarbons: To pass the test.
Sulfated ash: Not more than 0.05 per cent, determined on 2.0 g.

STORAGE
Store protected from light.

LABELLING
The label states the nominal drop point.

Certifications :
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP/BP/USP/NF/Ph. Eur, JP/ CP), Speciality Chemicals(Pure/AR/ACS), Mineral Fortifiers, Food Chemical Codex (FCC) and Flavour chemicals. Our manufacturing facility is cGMP, GLP, ISO 9001, ISO 14001, ISO 22000, ISO/IEC 17025, FSSC 22000, FSSAI, Kosher, HALAL, EXCiPACT, WC, COPP, WHO-GMP and WC certified. We are also REACH registered for export to European countries.