Pending revisions which have been approved for potential adoption are published on the compendial notices section of the uspnf website under notices of intent to revise. Lanolin is one of the best substances for use on delicate, dry or chapped skin as it provides a protective barrier on the skin and helps to hold moisture into the skin. All information provided in support of this product, including sds and any product information leaflets have been developed and issued under the authority of the issuing pharmacopoeia. Bovidae, that has been processed to reduce the contents of free lanolin alcohols and detergent and pesticide residues. Acetylated lanolin, hydrogenated lanolin, and hydroxylated lanolin result when acetate, hydrogen and hydroxyl groups are added to lanolin, respectively. Certain breeds of sheep produce large amounts of lanolin, and the extraction can be performed by squeezing the sheeps harvested wool between rollers. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020, wolters kluwer updated. Stage 6 harmonization official december 1, 2014 alcohol 1 table 1 continued alcohol hold time initial tempera final at final add the following. The information and materials provided is for educational purposes only. It is a strong wo emulsifier in the form of a hard, semicrystalline wax and fulfils the requirements of the monograph wool alcohols of the european pharmacopoeia. Is an excellent emollient and is easy to be absorbed by the skin. Dissolve about 100 mg, accurately weighed, in 12 ml of warm about 60 90 percent alcohol. Lanolin anhydrous usp introduction lanolin is a natural, waxy substance derived from crude wool wax also often referred to as wool grease or wool fat.
Content of sterols as cholesterol melt 20g of lanolin alcohols on a water bath,mix,and allow to cool. Lanolin is fairly dense and will not fill containers to full. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. When reacted with propylene and ethylene oxides in a variety of ratios, it performs as a nonionic sur. Lanolin alcohol ssr ep is the super refined unsaponifiable fraction of lanolin comprising a mixture of cholesterol, lanosterol, agnosterol and their dihydro derivatives plus straight and branched chain aliphatic alcohols.
Lanolin anhydrous usp grade is a natural, high quality purified lanolin derived from sheeps wool. Lanis lanolin anhydrous adeps lanae anhydricus, lanolin. Copper meets ep usp alkalinity meets ep usp colour gardner 8 max. We provide different qualities for different areas of application. Lanolin alcohols united states pharmacopeia usp reference. Combine the filtrate and washings,add 20mlof a freshly. As we approach our 200th anniversary year in 2020, usp ceo ron. Our lanis lanolins and its various derivatives complex blends of alcoholic and acidic fatty esters have an unmatched performance and safety record in the pharmaceutical and cosmetic industry. Table 1 continued alcohol initial tempera final at final. Modified lanolin is the purified waxlike substance from the wool of sheep, ovis aries linne fam.
Lanolin alcohols, chemical structure, molecular formula. In each instance, a distinctly positive reaction was elicited by each of the lanolin preparations, by the proprietary ointment containing lanolin alcohols, by the mixed lanolin alcohol fraction and by the lanolin fatty. It can be used in the most exacting applications where color, odor and purity are critical. Acidity neutralize 50 ml of alcohol containing 1 ml of phenolphthalein ts with 0. The highest quality standards are defined by the european pharmacopoe ia ph. Semi crystalline, light amber to yellow wax, typical lanolin. Lanolin oil usp liquid natures garden soap making supplies.
Lanowax ep is distinguished from normal lanolin alcohol by its bright colour and faint odour. Acetylated lanolin alcohol results when acetate is added to lanolin alcohol. Anhydrous lanolin usp is produced from the multistage refining of wool grease, it is manufactured to fully meet the requirements of the current usp monograph. It consists of a highly complex mixture of esters of high molecular weight aliphatic, steroid or triterpenoid alcohols and fatty acids. With an area of 53,500 square metres, our jurong plant is capable of converting 10,000 tonnes of woolgrease into lanolin, lanolin derivatives and cholesterol.
Lanolin wool fat, adeps lanae, wool wax, degras is defined in the united states pharmacopeia xiii 1947 as. Unlike vegetable, nut, or seed oils, it contains no triglycerides. Due to inconsistencies between the drug labels on dailymed and the pill images provided by rximage, we no longer display the rximage pill images associated with drug labels. Lanolin wool fat, adeps lanae, wool wax, degras is. Lanolin is a natural, waxy substance derived from crude wool wax also often referred to as wool grease or wool fat. Petrolatum passes residual solvents passes foreign substances usp. Dissolve about 100mg,accurately weighed,in 12mlof warm about 6090percent alcohol. Lanolin from latin lana wool, and oleum oil, also called wool yolk, wool wax, or wool grease, is a wax secreted by the sebaceous glands of woolbearing animals. In burns dressings, lanolin supports the wound healing process and enhances dermal repair. The level of residue of pesticides1 and other chemical indicators is decisive for the quality of the lanolin. Its obtained from the liquids resulting from scouring sheep wool. To the sample solution add 1 ml of phenolrb 1aug2016. Combination of fatty alcohol and fatty acids, resulting from.
Lanolin alcohol cosmetic grade is the refined, unsaponifiable fraction of lanolin, composed of a complex mixture of cholesterol, lanosterol and their dihydro derivatives plus straight and branched chain aliphatic alcohol. Lanolin wool fat, adeps lanae, wool wax, degras is defined. La109, lanolin, usp table of contents product specification safety data sheet sds certification of quality management system qms. Due to inconsistencies between the drug labels on dailymed and the pill images provided by rximage, we no longer display the rximage pill images associated with drug labels we anticipate reposting the images once we are able identify and filter out images that do not match the information provided in. The use of lanolin acids in topical products for cutaneous infections e. Lanolin is secreted by the sebaceous glands of the merino sheep, resulting in a yellow waxy substance.
Theyre what patients deserve and what usp strives to ensure across the globe through the development of public quality standards. Ethyl alcohol insoluble soluble clear solution water insoluble insoluble levels of use the level of use of the lanolin will depend on the. Lanolin used by humans comes from domestic sheep breeds that are raised specifically for their wool. Nk ingredients pte ltd formally known as nk chemicals pte ltd was established in 1994 to manufacture lanolin and its derivatives. Portions of this monograph that are national usp text, and are not part of the harmonized text, are marked with 40 10240 symbols. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020. This product is made with manufacturing processes that reduce certain allergens in the lanolin. Dissolve 10 ml of benzyl alcohol in 10 ml of the neutralized alcohol, and titrate with 0. Lanolin usp pharmaceutical grade lanolin has a wide range of applications because of its colloidal chemical properties and compatibility with a broad range of ingredients. Most or all of the lanolin is removed from wool when it is processed into textiles, such as yarn or felt. The purpose of this chapter is to give you basic knowledge about ointment bases and their ingredi. Individuals receiving this information must utilize their independent judgment in determining.
Also called adeps lanae, wool wax, wool fat, anhydrous wool fat or wool grease, is a greasy yellow substance secreted by the sebaceous glands of woolbearing animals. In addition, it has powerful wo emulsifying properties, which allows the product to function as an unsurpassed moisturizer that can smooth and soften the skin. Soluble in hot alcohol soluble in carbon disulfide sparingly soluble in cold alcohol product code. Assay inject about 5 l of isopropyl alcohol into a suitable gas chromatograph, equipped with a thermal conductivity detector. This group of ingredients is used extensively in cosmetics as well as in many other consumer products. Tempera ture tempera temperature ramp ture ture min min. Lanolin has a shelf life of 2 two years from date of manufacture. It is manufactured to fully meet the requirements of the current monograph of the usp. Allow to stand for 18hours,pass through a mediumporosity,sinteredglass filter,and wash the residue with two 15mlportions of 90percent alcohol. Under typical conditions, the gas chromatograph contains a 1. Today we operate the largest, most modern, integrated lanolin manufacturing operation in the world. Anhydrous lanolin usp acts as an naturally derived emollient and is readily absorbed by the stratum corneum where it reduces excess moisture loss and restores softness and elasticity to dry skin.
Lanolin pharmaceutical grade superb skin protector as well as being well tolerated by the body it is approved for uses in ophthalmic emollients and as a food additive in chewing gum bases lanolin is also of medical interest. Customers should always refer to the ingredients label as affixed to each product or the material safety data sheet specification sheet which are current at the time of supply of the product. Lanolin and its related ingredients are widely used in the formulation of cosmetics and personal care products. Lanolin oil usp liquid is a bulk carrier oil from natures garden soap making supplies. This group of ingredients is used extensively in cosmetics as.
Wool fat test specification min max melting range 38 44c iodine value 18 36 acid value 2. Apr 01, 2019 the active ingredients of the product consist of any of the following. This fatlike substance is in many respects analogous to human sebum in its. Find our expansive list of ingredients and raw materials here. Lanolin s waterproofing property aids sheep in shedding water from their coats.
The difference between the number of ml of 1 n sodium hydroxide consumed in the test with the sample and that consumed in the blank test, multiplied by 56. Lanolin oil provides waterproofing and moisturizing to skincare products and is excellent in lip care formulations. This lanolin liquid is used in homemade bath and body recipes. It also contains sterol esters and squalane, a bioidentical ingredient found in our skins sebum and stratum corneum. The wax is separated from the liquid using high speed centrifugation. Content of sterols as cholesterol melt 20 g of lanolin alcohols on a water bath, mix, and allow to cool. Why is dailymed no longer displaying pill images on the search results and drug info pages.
Derived from sheeps wool, lanolin is a type of natural wax composed of esters and hydroxy esters of lanolin acids and lanolin alcohols lanolin alcohols are part of the unsaponifiables in lanolin. Lanolin topical for the skin is used to treat or prevent dry skin, itching or other skin irritation caused by conditions such as diaper rash, radiation therapy skin burns, and others. Safety data sheet according to 29cfr19101200 and ghs rev. Specification for lanolin, usp la109 item number la109 item lanolin, usp cas number 8006540 molecular formula molecular weight mdl number synonyms refined wool fat. Lanolin usp modified anhydrous lanolin usp modified is produced from the multistage refining of wool grease, a natural, renewable raw material which is obtained from the scouring washing of raw wool. Lanolin is a natural substance found in sheeps wool. Allow to stand for 18 hours, pass through a mediumporosity, sinteredglass filter, and wash the residue with two 15ml portions of 90 percent.
In this monograph, the limit of total pesticides was reduced to 3 ppm total pesticides, with no individual limit greater than 1 ppm. It can be used in many applications where color and odor are critical. Lanolin is a soft, natural wax, obtained from wool grease. In 2000, the european pharmacopoeia introduced pesticide residue limits into its lanolin. Mar 05, 2020 lanolin is a natural substance found in sheeps wool. Usp volunteers help shape the future of drug manufacturing. Table 1 continued alcohol hold time initial tempera final at final add the following. It is produced by alkaline hydrolysis of lanolin feedstock, followed by further refining. Monograph id numbers inci names 252019 1 monoid inciname 1 abietic acid 2 abietyl alcohol 5 acetaldehyde 6 acetamide mea 7 acetanilid 8 acetic acid.
Pending monographs are published for comment in the inprocess revision section of the pharmacopeial forum. Allow to stand for 18 hours, pass through a mediumporosity, sinteredglass filter, and wash the residue with two 15ml portions of 90 percent alcohol. Lanolin conforming to this monograph is intended for use in more exacting applications, for example on open wounds. Lanolin oil usp this liquid form of lanolin in much less viscous than typical lanolin, and is produced by heating lanolin at low temps to remove the liquid esters in lanolin. General description this product is provided as delivered and specified by the issuing pharmacopoeia. Anhydrous lanolin can act as a carrier for pharmaceutically active ingredients that have to be transported into deeper layers of the skin. It is useful in pharmaceutical preparations, salves and ointments, as well as having functional attributes as an epidermal moisturizer, lubricant and emollient. Lantiseptic original skin protectant cream santus llc. Pending revisions which have been approved for potential adoption are published on the compendial notices section of the usp nf website under notices of intent to revise.