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Captex® 200P

Captex® 200P is propylene glycol diesters of saturated fatty acids, mainly of caprylic and capric acids of vegetable origin. The low viscosity, excellent lubricity, and relatively non-oily character of Captex® 200P makes it ideally suited for a variety of pharmaceutical and clinical nutritional applications, including microemulsions, soft-gelatin capsules, suspensions, and suppositories. It is manufactured in USA.

Brand: Captex (28 products)

Chemical Name: Propylene Glycol Dicaprylate, Propylene Glycol Dicaprylocaprate

Functions: Bioavailability Enhancer, Carrier, Solubilizer, Viscosity Modifier

Dosage Form: Capsules, Creams, Lotions, Ointments, Soft Gels, Suppositories, Suspension

Labeling Claims: Aflatoxin-free, BSE-free, CMR Substances-free, Kosher, Mycotoxins-free, Non-GMO, Polychlorinated Biphenyls (PCB)-free, TSE-free, Vegan

Certifications & Compliance: BRC Certified, European Pharmacopeia (Ph. Eur.), FDA Compliant, GFSI Certified, GMP, Generally Recognized As Safe (GRAS), Hazard Analysis Critical Control Point (HACCP), ISO 14001, ISO 45001, ISO 9001, Kosher, The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA), United States Pharmacopeia (USP), Vegan

Technical Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name
Propylene Glycol Dicaprylate,
Propylene Glycol Dicaprylocaprate
Pharma & Nutraceuticals Functions
Bioavailability Enhancer,
Carrier,
Solubilizer,
Viscosity Modifier
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Carriers & Bulking Agents,
Formulation & Processing Aids,
Solvents & Solubilizers

Features & Benefits

Labeling Claims
Aflatoxin-free,
BSE-free,
CMR Substances-free,
Kosher,
Mycotoxins-free,
Non-GMO,
Polychlorinated Biphenyls (PCB)-free,
TSE-free,
Vegan

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Oral,
Rectal,
Topical,
Transdermal
Dosage Form
Capsules,
Creams,
Lotions,
Ointments,
Soft Gels,
Suppositories,
Suspension
Applications
  • Carrier (vehicle)
  • Bio-Availability Enhancer
  • Energy Source
  • Solubilizer
  • Viscosity modifier

Properties

Physical Form
Liquid
Appearance
Clear almost-colorless to light-yellow liquid
Typical Properties
ValueUnitsTest Method / Conditions
Cloud Pointmax. -15°C-
Fatty Acid Composition
ValueUnitsTest Method / Conditions
C1020.0 - 50.0%EP/NF
C12max. 3.0%EP/NF
C14max. 1.0%EP/NF
C6max. 2.0%EP/NF
C850.0 - 80.0%EP/NF
Elemental Impurities
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 0.1μg/g-
Cadmium Contentmax. 0.1μg/g-
Cobalt Contentmax. 1μg/g-
Lead Contentmax. 0.1μg/g-
Mercury Contentmax. 0.1μg/g-
Nickel Contentmax. 1μg/g-
Vanadium Contentmax. 1μg/g-
Specifications
ValueUnitsTest Method / Conditions
Acid Valuemax. 0.2mg KOH/g¹EP/²NF
Alkaline impurities (0.01N HCL)max. 0.15mLEP/NF
ColorPassAPHA3AOCS Cc 13j-
Hydroxyl Valuemax. 10mg KOH/gEP/NF
Identification Tests⁴Pass-EP/NF
Iodine Valuemax. 1cg I2/gEP/NF
Peroxide Valuemax. 1.0mEq/kgEP/NF
Saponification Value320 - 340mg KOH/gEP/NF
Total Ashmax. 0.1%EP/NF
Unsaponifiable Mattermax. 0.5%NF
Water Contentmax. 0.1%EP/NF
Note

1EP: European Pharmacopeia
2NF: United States Pharmacopeia/National Formulary
3AOCS: American Oil Chemists’ Society
4Compliance based on controls in place assuring ID of excipient

For Elemental Impurities : Data obtained for the samples were below the listed initial-results ranges levels. Initial-results ranges data are for informational purposes only and do not constitute specifications. Testing is expected to continue on a periodic basis for the material, however, the frequency is to be determined.

Regulatory & Compliance

Certifications & Compliance
BRC Certified,
European Pharmacopeia (Ph. Eur.),
FDA Compliant,
GFSI Certified,
GMP,
Generally Recognized As Safe (GRAS),
Hazard Analysis Critical Control Point (HACCP),
ISO 14001,
ISO 45001,
ISO 9001,
Kosher,
The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA),
United States Pharmacopeia (USP),
Vegan
Grade
Pharma Grade
Regulatory
  • Meets the current monographs: USP/NF- Propylene Glycol Dicaprylate/Dicaprate; European Pharmacopeia- Propylene Glycol Dicaprylocaprate.
  • Complies with US FDA 21 CFR § 172.856 for propylene glycol mono- and diesters of fats and fatty acids.

Safety & Health

Product Stewardship

ABITEC’s product stewardship rests with all individuals involved with the products, from the initial concept and research, to manufacture, testing, use, sale, storage, distribution and disposition of each product. Each individual takes the appropriate steps to protect employee health, public health and the environment./p>

Packaging & Availability

Packaging Type
Drums,
Jerrycan
Standard Packaging
  • 425 lb (192.8 kg) drum
  • 50 lb (22.7 kg) HDPE jerrican

Storage & Handling

Shelf Life
36 months
Recommended Storage and Handling
  • Store in tightly-sealed containers in a dry location at ambient temperature, protected from light.
  • Retest/requalify 36 months after date of manufacture.