Technical Data Sheet O
Lauryl Lactate HP, USDMF
(CH2) 11 H3C
O
OH
Applications Lauryl lactate is widely used in the pharmaceutical industry and specially for Topical products (i.e. Transdermal patches). Following is a list of key applications: • Emollient • Emulsifier • Excipient • Humectant • Penetration enhancer
General Information
Key Product Attributes
IP
Pharmacopeia Status
: In-house product
• Manufacturing and packing under GMP environment
CAS No.
: 6283-92-7
• Low Lactic acid contents
EC No.
: 228-504-8
Appearance / Description
: Clear Liquid
Molecular Formula
: C15H30O₃
Molecular Mass
: 258.4 g/mol
Pack Mode 500 gm glass bottle
Marketed Formulation
DMF (Drug Master File)
• Norelgestromin & Ethinyl Estradiol transdermal patch
USDMF registered product (DMF # 31766)
• Norelgestromin transdermal patch and more…
Stability and Storage Conditions Quality and Regulatory Support • GMP and ISO certification
Stable under recommended conditions. Keep container tightly closed in a cool, dry and well-ventilated place.
• EXCiPACT certification • Nitrosamine impurity risk assessment • Elemental impurity risk assessment
Safety and Handling Information
• Residual solvent declaration
Avoid contact with skin and eyes. Avoid breathing vapours,
• Genotoxic impurity declaration
mist or gas. Ensure adequate ventilation. A laboratory
• Vendor questionnaire and site audit
fume hood or other appropriate form of local exhaust
• CMC documentation
ventilation should be used to avoid exposure. If exposed,
• Regulatory queries
evacuate personnel to safe areas. Wash affected area with soap and water. Consult a physician if any exposure symptoms are observed.