98% Vitamin K1 API from GMP Factory

What is Vitamin K1 API used for?

Vitamin K1 API is used as the active ingredient in injectable and oral products for the reversal of warfarin‑induced anticoagulation, treatment of vitamin K deficiency bleeding (VKDB) in neonates, and management of malabsorption syndromes. Compounding pharmacies use it to prepare low‑dose capsules and oral suspensions for patients requiring customized therapy.

What is the difference between Vitamin K1 (Phytonadione) and Vitamin K2 (menaquinone)?

Vitamin K1 is the naturally occurring form found in plants and is primarily involved in hepatic coagulation factor synthesis. Gut bacteria produce vitamin K2 (menaquinone) and have a longer half‑life, playing a role in bone and cardiovascular health. For anticoagulation reversal, K1 is the preferred and approved agent.

Are you a registered Vitamin K1 API supplier?

Yes. Our manufacturing facility is GMP‑certified for vitamin APIs and sterile injectable products. We have supplied Vitamin K1 API to generic drug manufacturers, hospital pharmacies, and compounding pharmacies globally.

Do you provide a Certificate of Analysis (COA) with each batch?

Yes. Every shipment includes a batch‑specific COA showing assay, cis/trans isomer ratio, impurity profile (including epoxide), water content, refractive index, and (for sterile grade) endotoxin and sterility results. Stability summary and MSDS are also provided.

Can you supply sterile Vitamin K1 injectable emulsion?

Yes. Our sterile injectable grade is a clear, preservative‑free solution of Vitamin K1 in a water‑miscible vehicle (polysorbate 80 and propylene glycol, or similar), ready for IV/IM/SC administration after dilution or as supplied. Each vial contains 10 mg/mL. We also provide empty vials and can custom‑fill to your specifications under contract.

What is the stability of Vitamin K1 in oral suspensions for compounding?

Vitamin K1 is lipophilic and photolabile. For oral suspensions, oil‑based vehicles (e.g., MCT oil or olive oil) with nitrogen overlay in amber bottles offer the best stability. Aqueous suspensions should be prepared extemporaneously and used within 14 days refrigerated. We provide accelerated stability data for specific vehicles upon request. Typical BUD for oil‑based oral suspension: 90 days refrigerated.

Do you offer Vitamin K1 in a ready‑to‑use injectable formulation?

We supply the sterile API concentrate in vials. We do not manufacture finished prefilled syringes or infusion bags, but we can provide technical guidance to compounding pharmacies and 503B facilities for aseptic dilution and filling.

How do you control the cis‑trans isomer ratio?

Vitamin K1 contains a double bond in the phytyl side chain. The trans‑isomer is the biologically active form. Our manufacturing process preserves the natural trans configuration. We test each batch by normal‑phase HPLC to ensure trans‑isomer content ≥ 90% of total. Degradation (light, heat) promotes cis‑isomer formation; our packaging (amber glass, nitrogen) minimizes this.

What is the lead time for delivery to North America or Europe?

Non‑sterile compounding grade: 4 days after order confirmation. Bulk grade: 7 days. Cold-chain express courier (2–5 days) is required for sterile-grade; ambient shipping is acceptable for non‑sterile oil if kept in light‑protected packaging. We maintain limited refrigerated safety stock in the USA (New Jersey) and the Netherlands (Rotterdam).

Can you provide R&D samples for formulation feasibility studies?

Yes. We offer free R&D samples (up to 500 mg of non‑sterile oil) to qualified pharmaceutical R&D departments and licensed compounding pharmacies. The customer pays only for shipping.

How do you compare with other Vitamin K1 API suppliers?

We combine GMP manufacturing with transparent, third‑party‑tested quality data (including full isomer and impurity profiles), shorter lead times via regional warehouses, and dedicated English‑speaking technical support. Unlike many suppliers, we actively support small‑volume compounding pharmacy orders (as low as 1 g) and provide BUD guidance for oil‑filled capsules and oral suspensions.

What is the recommended beyond‑use date (BUD) for compounded Vitamin K1 capsules?

For oil‑filled capsules (Vitamin K1 in MCT oil with 0.1% BHT antioxidant) stored in amber glass bottles with nitrogen overlay, refrigerated (2–8 °C), we recommend a BUD of 180 days. For dry-powder-filled capsules (using spray‑dried Vitamin K1 on a carrier), BUD is 90 days refrigerated. We provide BUD verification data for specific capsule shells and fill oils upon request.

Is Vitamin K1 stable at room temperature during compounding?

Short‑term exposure (less than 8 hours) to room temperature (15–30 °C) in ambient light during compounding is acceptable for non‑sterile oil. However, the bulk API should be returned to refrigeration (2–8 °C) immediately after use. Prolonged exposure to light or heat will accelerate cis‑isomer formation and epoxide degradation. Always use amber glass and minimize light exposure.

Can Vitamin K1 be used in pediatric and neonatal patients?

Yes. Vitamin K1 is the standard of care for neonatal prophylaxis of VKDB (0.5–1 mg IM within 6 hours of birth). Compounding pharmacies may prepare lower oral doses (0.5 mg, 1 mg, 2 mg) for infants with malabsorption or for breastfed infants at risk. We provide an API for such prescriptions, but strongly advise following published guidelines (AAP, CDC). We do not provide medical advice.

What is the solubility of Vitamin K1 in common vehicles?

Vitamin K1 is freely soluble in ethanol (> 100 mg/mL), ether, chloroform, and vegetable oils (soybean, MCT, olive oil: ≈ 50–100 mg/mL). It is practically insoluble in water (≈ 0.001 mg/mL). For oral suspensions, use oil‑based vehicles or incorporate into lipid emulsions. For injectable preparations, use commercially available sterile emulsion vehicles or polysorbate 80/propylene glycol blends.

What are the signs of Vitamin K1 degradation?

Degradation (by light, heat, or oxidation) results in a color change from yellow‑amber to brown, formation of a precipitate, or a decrease in assay. Degradation products include cis‑Vitamin K1, Vitamin K1 epoxide, and dimers. Any vial showing discoloration, cloudiness, or precipitate should be discarded.