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MCT Oil

Pharmaceutical Grade MCT Oil — ChP 2025 Excipient

Pharmaceutical grade MCT oil in a 190 kg iron drum


Pharmaceutical-grade medium-chain triglycerides (MCT oil) manufactured to the requirements of the Chinese Pharmacopoeia (ChP 2025, Volume IV). Supplied as a clear, colourless to slightly yellowish oily liquid for use as an excipient / carrier in topical and oral preparations, and as a high-purity base in cosmetic formulations.

Shandong Nametai Biotechnology Co., Ltd. is a China-based MCT Oil manufacturer and MCT Oil supplier producing pharmaceutical-grade MCT Oil for pharmaceutical excipient applications and other controlled formulation requirements. The material is manufactured at our Dongying plant in Shandong and supplied directly to formulators, contract manufacturers and distributors.

Basic Product Information

ItemDetails
Chemical nameMedium-chain triglycerides (pharmaceutical grade)
INCI nameCaprylic/Capric Triglyceride
AliasPharmaceutical Grade MCT Oil
Molecular weight400 – 500 g/mol
AppearanceClear, colourless to slightly yellowish oily liquid
Grades availableChP 2025 (pharmaceutical excipient grade) & food grade

Component Profile

ComponentEINECS No.CAS No.
Glyceryl Trioctanoate208-686-5538-23-8
Glyceryl Tricaprate210-702-0621-71-6

Specification — Physicochemical

ParameterUnitSpecification (Standard)Method
Appearance—Clear, colourless to slightly yellowish oily liquid; freely soluble in methanol, practically insoluble in waterVisual
Identification—Retention times of methyl octanoate and methyl decanoate peaks conform to the reference solutionChP 0521
Relative density (20°C)—0.93 – 0.96ChP 0601
Refractive index (20°C)—1.440 – 1.452ChP 0622
Viscosity (25°C)mPa·s25 – 33ChP 0633
Acid valuemg KOH/g≤ 0.2ChP 0713
Hydroxyl valuemg KOH/g≤ 10ChP 0713
Iodine valueg I₂/100 g≤ 1.0ChP 0713
Peroxide valuemeq/kg≤ 1.0ChP 0713
Saponification valuemg KOH/g310 – 360ChP 0713
Clarity and colour of solution—Clear and colourless; not deeper than reference solution Y3ChP 0901
Unsaponifiable matter%≤ 0.5ChP 0713
Alkaline impuritiesml≤ 0.15 ml of 0.01 mol/L hydrochloric acid VS—
Water%≤ 0.2ChP 0832
Residue on ignition%≤ 0.1ChP 0841

Specification — Fatty Acid Composition

Fatty acid (of total fatty acids)Specification
Caproic acid C6:0≤ 2.0%
Caprylic acid C8:050.0% – 80.0%
Capric acid C10:020.0% – 50.0%
Lauric acid C12:0≤ 3.0%
Myristic acid C14:0≤ 1.0%
≥C16 fatty acids≤ 1.0%

Specification values are per the referenced standard; a batch COA with actual test results is issued with each shipment. Custom specifications (C8:C10 ratio, packaging, private label) are available on request.

Every batch is tested in our own laboratory — see inside our QC lab (Agilent 7890B GC).

Quality control laboratory at the Nametai MCT oil factory


Source & Ratio Options

Raw material sourceC8:C10 ratio
Palm oil60:40 / 70:30
Coconut oil60:40 / 70:30

Applications

  • Excipient / carrier for ointments, creams, gels and oral preparations — improves dispersion and penetration of the active ingredient.
  • High-purity emollient base for premium cosmetics and sensitive-skin formulations; light, non-greasy skin feel.
  • Solubiliser and dilution medium for fat-soluble actives, flavours and pigments.
  • Oxidation-resistant and hydrolysis-resistant — extends the shelf life of finished formulations.

Packaging

ContainerLiquid pharmaceutical-grade high-density polyethylene container

Packaging container per the product TDS. Commercial pack sizes and pallet configuration are confirmed at order stage.

Documents Supplied

  • Batch COA (Certificate of Analysis) with every shipment
  • Technical Specification Sheet (EN/CN)
  • Third-party laboratory test report available upon request
  • ISO 9001 / ISO 22000 / ISO 14001 / ISO 45001 certificates
  • HACCP certificate
  • HALAL and Kosher certificates
  • Food Production Licence
  • FDA food facility registration (a facility registration only — not an FDA product approval)

For guidance on reading the batch COA, see how to read an MCT oil COA.

Buyers who need to qualify a supplier before ordering can request the technical data sheet (TDS), the specification sheet and a batch COA in advance of shipment, so that the documentation package can be reviewed together with a sample.

NMPA excipient filing evidence for pharmaceutical grade MCT oil

NMPA Excipient Filing Evidence for Pharmaceutical Grade MCT Oil (CDE filing no. F20260000425)

Regulatory note: the China CDE excipient filing and the ChP specification do not automatically prove compliance with market-access or pharmacopoeia requirements in other markets; specific requirements must be confirmed separately for your destination and intended use.

Storage & Shelf Life

Keep tightly sealed in a cool, dry store, away from direct sunlight and heat. Unopened shelf life is 24 months from the date of manufacture when stored as recommended.

Related Products

Medium-Chain Triglycerides (MCT)  |  Caprylic/Capric Triglyceride (GTCC)  |  Caprylic/Capric Triglyceride (ODO) - Food Grade  |  Glyceryl Trioctanoate (Pure C8)  |  All MCT Oil Products

FAQ

What is pharmaceutical-grade MCT oil?

It is medium-chain triglycerides manufactured to the requirements of the Chinese Pharmacopoeia (ChP 2025, Volume IV) and supplied as an excipient / carrier for topical and oral preparations. Appearance, identification, relative density, refractive index, viscosity, acid value, saponification value, water and the other parameters listed above are tested against the pharmacopoeial methods shown in the specification table.

What is the difference between pharmaceutical-grade and food-grade MCT oil?

Both are the same substance, but they are released against different standards and different paperwork: this grade is tested to ChP 2025 excipient requirements, while the food-grade material is supplied against food standards. The parameters that differ are set out in pharmaceutical-grade vs food-grade MCT oil. For a structured audit checklist of the manufacturer itself, see how to choose an MCT oil manufacturer for pharmaceutical applications.

What quality documents are supplied?

Each shipment is accompanied by a batch COA, a technical specification sheet (EN/CN), a third-party laboratory test report (available upon request), ISO 9001 / ISO 22000 / ISO 14001 / ISO 45001 certificates, HACCP, HALAL and Kosher certificates, the food production licence and the US FDA facility registration.

Does each batch come with a COA?

Yes — a batch COA with actual test results is issued with every shipment.

What are the applicable pharmacopoeial requirements?

This grade is produced to the Chinese Pharmacopoeia, ChP 2025, Volume IV. The specification table above lists each pharmacopoeial test method (ChP 0521, 0601, 0622, 0633, 0713, 0832, 0841 and 0901) together with the standard limit and the test method.

What documentation can you provide for our regulatory dossier?

Each batch ships with a COA carrying actual test results. The specification sheet (TDS), MSDS and the China CDE excipient filing evidence (filing no. F20260000425) are available on request and can be reviewed together with a sample. These documents support your own market-access review — the China excipient filing is a filing, not an approval in other jurisdictions.

Supplied factory-direct from our production base in Dongying, Shandong. Ready to request a quotation, a batch COA or a 1 kg sample? Contact our sales team — Tel / WhatsApp +86 132 9546 7567.

Quality & compliance: quality control, certifications and supplier due-diligence support for this product are described in our Quality & Compliance section.

Manufacturing & Quality

This product is manufactured by Shandong Nametai Biotechnology Co., Ltd. at its Dongying plant (Yellow River Delta Agricultural High-tech Zone, Shandong), a 5,220 m² facility with an annual capacity of 10,000 tonnes. Production uses esterification, molecular distillation and dedicated pharma-grade finishing.

Every batch is tested in our in-house QC laboratory before release, covering the parameters listed in the specification table above. Heavy metals, plasticizers and microbiological items are verified through third-party laboratory reports. A batch COA is issued with each shipment.

The site holds ISO 9001, ISO 22000, ISO 14001, ISO 45001, HACCP, Kosher, HALAL, FDA food-facility registration and a China food production licence, all issued to Shandong Nametai Biotechnology Co., Ltd. The issuing body is printed on each certificate so it can be verified independently.

Typical use of this product: pharmaceutical excipient applications. To review the facility, the QC laboratory and the certificates held by the manufacturing site, see our factory and our certifications. For batch documentation, samples or a quotation, request a quote.

Commercial Terms

Minimum Order Quantity

The minimum order quantity is 1 kg for MCT Oil, MCT Powder and Specialty Esters.

Samples

Samples are available in 1 kg or 20 kg quantities, and sample quantities can also be customized according to customer requirements.

Lead Time

Regular orders: 7 days to port of departure. Samples: within 7 days to the port of departure, depending on sample quantity. OEM / custom orders: within 30 days from the order date.

Documentation

A batch COA (Certificate of Analysis) carrying the actual test results is issued with each shipment. TDS can be provided with shipment or upon request. Further documentation requirements can be discussed at the enquiry stage.

OEM / ODM

OEM / ODM services are available. Custom formulation requests can be evaluated according to product requirements.

Packaging

Standard packing is shown in the packaging table on this page. Pallet configuration for bulk shipments is confirmed at order stage. Other pack sizes can be discussed per order.

Nametai supports bulk supply of MCT Oil with product specifications, TDS, batch COA and samples available for buyer evaluation. Goods are supplied in liquid pharmaceutical-grade high-density polyethylene containers per the product TDS; pack sizes and pallet configuration for bulk orders are confirmed at order stage.

Payment

Payment terms are agreed upon according to the contract between both parties.

For the documentation behind excipient sourcing, compare pharmaceutical-grade vs food-grade MCT oil, and see how batch testing works in our QC lab.

For a quotation, a sample or batch documentation, please submit via our enquiry form — request a quote.