99% Vitamin D2 API Of GMP Factory
Vitamin D2 (Ergocalciferol) is a fat‑soluble secosteroid produced by ultraviolet irradiation of ergosterol from yeast or fungi. It is biologically active as a prohormone, regulating calcium and phosphorus homeostasis, bone mineralization, and immune function. Vitamin D2 is used both as a dietary supplement and as a prescription drug for the treatment of vitamin D deficiency, hypoparathyroidism, rickets, and certain metabolic bone diseases.
Our Vitamin D2 API is manufactured in a GMP‑compliant facility under strictly controlled conditions to ensure photostability, low impurities, and precise potency. It is suitable for oral capsules, softgels, injectable solutions, and fortified pharmaceutical formulations.
Compounding pharmacies also use it to prepare customized high‑dose capsules and oral solutions for patients with malabsorption syndromes.
Why Import Our Vitamin D2 API
#1. High quality:
Our strict Good Manufacturing practices and relentless Quality Control ensure supreme quality.
#2. Docs for registration available:
The complete set of registration documents from the manufacturer (GMP/DMF) is available for your MOH registration prior to import.
#3. Quality insurance:
We give you our word on the quality of our pharma-grade Vitamin D2.
It is produced strictly in accordance with cGMP requirements and certified by the State GMP. If there are any quality issues, you will either receive a refund or a free exchange at our expense.
Vitamin D2 Applications and Specifications
Applications:
Vitamin D2 API is used in the following pharmaceutical and compounding applications:
Oral capsules and softgels – for vitamin D deficiency, osteoporosis, and rickets. Typical strengths: 400 IU, 800 IU, 1,000 IU, 2,000 IU, 10,000 IU, 50,000 IU (prescription strength).
Injectable solutions – for rapid correction of severe deficiency or malabsorption (e.g., intramuscular ergocalciferol injection, 500,000 IU/mL).
Compounded oral solutions (oil‑based or aqueous) – for pediatric, geriatric, or bariatric patients who cannot swallow capsules. Custom strengths (e.g., 1,000 IU per drop).
Compounded capsules with adjusted potency – for patients requiring precise, non‑standard dosing (e.g., 25,000 IU twice weekly).
Pharmaceutical fortified foods (bulk API for industrial use) – not the primary focus, but available upon request.
For compounding pharmacies: Our Vitamin D2 API is available in micronized and non‑micronized forms, with custom packaging from 1g to 100g. We provide full stability data for oil‑based suspensions (MCT oil, olive oil, sesame oil) and aqueous vehicles.
Product Name: Vitamin D2 APIs (维生素D2)
Appearance: A white crystal
Solubility: Freely soluble in alcohol
Cas Number: 50-14-6
Molecular Formula: C28H44O
Molecular Weight: 396.65 g/mol
Chemical Name: (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-1-[(E,2R,5R)-5,6-dimethylhept-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol
HS Code: 2936290090 (other unmixed vitamins and their derivatives-其它未混合的维生素或其衍生物)
Suitability to be shipped by air as common goods: suitable. It is safe to be shipped by air as common goods.
Grade: Pharma-Grade
Purity or Assay: 99%
Standards: Current USP/BP Standards
Manufacturer Certificates available: ISO/GMP
Documents Available: COA/DMF/MSDS/TDS
Supply Capability: 100+ KG per year
MOQ: 100 G
Price Ideas In 2024: 1500 USD/100 G (For more updated prices, contact us directly by email or WhatsApp)
Lead Time: 5~7 days for quantities less than 10 KG, 3~4 days for orders less than 1000 G.
Stock Status: Over 10 KG
Shipping Temperature: Room temperature
Storage: Room temperature
Why Choose Us as Your Vitamin D2 API Supplier?
Pharmaceutical manufacturers and compounding pharmacies select us for these five key advantages:
1. High Purity & Compliance with Global Pharmacopeias
Assay (HPLC): 97.0% – 103.0% (USP) / 97.0% – 102.0% (EP)
Impurity control: Vitamin D2 related compound A (pre‑vitamin D2) ≤ 1.0%
Total impurities (excluding pre‑vitamin D2) ≤ 2.0%
Residual solvents meet ICH Q3C limits
Full batch‑by‑batch COA, stability data, and reference standards available
2. Reliable Supply Chain with Light‑Protected Handling
Annual production capacity: 5+ metric tons
Lead time: 7–10 days for standard grade; 14 days for micronized
All packaging includes light‑protected, oxygen‑barrier materials (aluminum bags with nitrogen flush)
Regional warehouses in North America, Europe, and Asia
3. Tailored Grades for Different Applications
Standard grade – for oral capsules and tablets (D90 < 100 µm)
Micronized grade – for improved dissolution and blend uniformity in low‑dose formulations (D90 < 30 µm)
Compounding grade – low endotoxin, available in 1g, 2g, 5g, 10g, 25g amber vials with nitrogen overlay
Injectable grade – sterile filtered, pyrogen‑tested, filled under nitrogen in crimp vials (for 503B compounding or hospital pharmacies)
4. Regulatory & Technical Documentation
DMF Type II (US, Canada, EU, China) available for cross‑reference
Complete impurity profile, including photodegradation products (tachysterol, lumisterol)
Technical support for formulation development: compatibility with fill oils (MCT, soybean, olive), antioxidants (BHA, BHT, vitamin E), and encapsulation processes
5. Compounding‑Friendly Policies
Low MOQ: 5g for compounding grade (no minimum for sample requests)
Free R&D samples (up to 500 mg) for qualified pharmacies
Stability protocols and beyond‑use dating (BUD) guidance for oil‑based and aqueous suspensions
FAQs About Our Vitamin D2 API
Q1: What is Vitamin D2 API used for?
A1: Vitamin D2 API is used as an active pharmaceutical ingredient in prescription and over‑the‑counter products for vitamin D deficiency, hypoparathyroidism, rickets, osteomalacia, and certain renal bone diseases. It is also used by compounding pharmacies to prepare high‑dose capsules and oral solutions for patients with malabsorption or who require non‑standard dosing.
Q2: What is the difference between Vitamin D2 (Ergocalciferol) and Vitamin D3 (Cholecalciferol)?
A2: Vitamin D2 is derived from yeast/fungal sources (ergosterol + UV light) and is often used in prescription products. Vitamin D3 is derived from lanolin or fish oil. For most patients, both are effective, but some studies suggest D3 may be more potent in raising serum 25‑hydroxyvitamin D levels. Compounding pharmacies may stock both. We offer both APIs.
Q3: Are you a registered Vitamin D2 API supplier?
A3: Yes. Our manufacturing site is GMP‑certified for vitamin APIs. We have supplied Vitamin D2 API to generic drug manufacturers, OTC supplement companies, and compounding pharmacies globally.
Q4: What is your minimum order quantity (MOQ) for compounding pharmacies?
A4: For licensed compounding pharmacies, our MOQ is 100 grams for non‑sterile compounding grade.
Q5: How do you protect Vitamin D2 from degradation during shipping?
A5: All shipments are packaged in light‑impermeable aluminum foil bags or amber vials, with nitrogen flush and oxygen absorbers. We include temperature monitoring on request (refrigerated shipping recommended for long‑term stability, but ambient shipping is acceptable for up to 2 weeks).
Q6: Do you provide a Certificate of Analysis (COA) with each batch?
A6: Yes. Each batch includes a COA showing assay, impurity profile (including pre‑vitamin D2), water content, residual solvents, particle size (if applicable), and (for sterile grade) endotoxin and sterility results. Stability data and MSDS are also provided.
Q7: Can you supply micronized Vitamin D2 API for better blend uniformity?
A7: Yes. Our micronized grade (D90 ≤ 30 µm) is specifically designed for low‑dose oral capsules (e.g., 400 IU, 800 IU) where content uniformity is critical. Micronization also improves dissolution in oil‑based softgels.
Q8: Is Vitamin D2 API available in sterile form for injectable compounding?
A8: Yes. We offer sterile, sterile‑filtered Vitamin D2 API in sealed amber vials under nitrogen. This grade is pyrogen‑tested and meets USP <71> sterility standards. It is ideal for 503B compounding facilities and hospital pharmacies preparing injectable ergocalciferol.
Q9: What documentation do you provide for regulatory filing?
A9: We provide a complete DMF Type II, including synthetic route, impurity profile (with forced degradation and photostability studies), method validation, stability data (accelerated and long‑term), elemental impurities (ICH Q3D), and residual solvent analysis.
Q10: How do you control photodegradation products like tachysterol and lumisterol?
A10: Our entire manufacturing and packaging process is conducted under yellow light with minimal oxygen exposure. All final packaging is light‑impermeable and nitrogen‑flushed. We test for specified photodegradants using validated HPLC methods to ensure levels are below ICH and pharmacopeia limits.
Q11: What is the lead time for delivery to North America or Europe?
A11: Standard grade: 3~5 days after order confirmation. Micronized grade: 14 days. Sterile injectable grade: 21 days. Express courier (2–5 days) is available.
Q12: Can you provide R&D samples for formulation feasibility studies?
A12: Yes. Free samples up to 500 mg for qualified manufacturers and licensed compounding pharmacies (shipping cost only). For larger feasibility batches (1–5g), we charge a nominal fee credited against the first commercial order. An MTA is required.
Q13: What is the recommended beyond‑use date (BUD) for compounded Vitamin D2 oral suspensions?
A13: For oil‑based suspensions (MCT, olive, sesame oil) with ≤ 0.1% BHT/BHA, we recommend 90 days refrigerated. For aqueous suspensions with preservatives (potassium sorbate, parabens): refrigerate for 30–45 days. We provide accelerated stability study summaries for specific vehicles upon request.
Q14: Can Vitamin D2 API be used in vegan or vegetarian products?
A14: Yes. Our Vitamin D2 is derived from yeast (ergosterol) – no animal sources. It is suitable for vegan, vegetarian, and halal/kosher formulations upon request (certificates available). Vitamin D3 from lanolin is not vegan, but we also supply D3 if needed.
Q15: What is the stability of Vitamin D2 API in softgels?
A15: When incorporated into oil‑based softgels with appropriate antioxidants (e.g., 0.05% BHA/BHT), Vitamin D2 is stable for 24 months when stored at controlled room temperature (15–30 °C) in light‑protected blister packs. We provide stability data for specific oil types (soybean, MCT, olive, sunflower) upon request.
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