Ascorbic Acid Injection 500mg/5mL

Ascorbic Acid Injection 500mg/5mL: What the Published Guidance Says

Our largest functional group by product count — from the individual vitamins and minerals carried on the WHO Model List through to parenteral nutrition components and finished multivitamin presentations.

This page collects the supply-relevant facts for Ascorbic Acid Injection 500mg/5mL — specification, testing, packaging and the registration paperwork that travels with the batch.

• The Model List sections that carry this portfolio Vitamins and minerals sit in section 27 of the 24th WHO Model List (2025). The listings include ascorbic acid, cholecalciferol and ergocalciferol, iodine, nicotinamide, pyridoxine and retinol, alongside calcium and other minerals. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
• Presentation matters as much as molecule An essential medicine is meant to be provided in an appropriate dosage form for the intended use and patient. A clinic that stocks the right molecule in an inappropriate presentation has met availability and missed usability — which is why we supply chewables, effervescents, drops, syrups and injectables across the same active ingredients. WHO — Essential medicines (fact sheet)
• The economic case for essential medicines is documented WHO reports that medicines account for 20–60% of health spending in developing countries, with up to 90% of the population purchasing medicines through out-of-pocket payments, making medicines the largest family expenditure item after food. The 2025 Model List covers over 520 medicines, including 374 for children. WHO — Essential medicines (fact sheet)

We quote these sources rather than paraphrase them loosely, because the detail matters commercially for Ascorbic Acid Injection 500mg/5mL. Where your national list differs from the WHO listing, the national list governs what may be supplied and promoted locally.

Ascorbic Acid Injection 500mg/5mL — Supply Parameters

The same therapeutic range is supplied in several presentations, so one purchase order can cover a mixed requirement: Alpha-Lipoic Acid Injection 5ml:125mg, L-Carnitine Injection 2ml:500mg, Pyridoxine Injection 1ml:100mg, Glutathione Injection 3000mg, Coenzyme Q10 Injection 2ml:5mg, Biotin Injection 5ml:500μg, Levocarnitine Injection 5ml:1000mg, Iron Sucrose Injection 5ml:100mg Ampoule.

Quality Control, Pharmacopoeial Standards & Documentation

Products are manufactured and tested against USP, EP, BP and CP monographs, with incoming raw-material inspection, in-process monitoring and full finished-product testing.

Every batch of Ascorbic Acid Injection 500mg/5mL is tested to the monograph stated on the purchase order. Where a monograph is silent on the presentation, we agree a written specification with you in advance and reference it on the certificate of analysis.

Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.

A typical release panel for this presentation covers:

• Testing for related substances and impurities
• Testing for dissolution or release profile (solid oral forms)
• Testing for uniformity of dosage units
• Testing for water content and pH where applicable
• Testing for sterility and bacterial endotoxins (parenterals and ophthalmics)
• Testing for microbial limits and preservative efficacy (multi-dose presentations)

COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.

Packaging, Labelling & Export

• Pack size: 5mL amber glass ampoule. Non-standard pack sizes can be quoted against your artwork.
• Storage: Store below 25°C, protected from light. Do not freeze. Keep ampoule in outer carton until use..
• Shelf life: 24 months (unopened). Stability data for the marketed pack is included in the dossier.
• Labelling: artwork can be produced in English, Arabic, French, Russian and Spanish, with your own brand and language mix, subject to the labelling rules of the destination market.
• Export: GMP certificate, COA, certificate of origin, packing list and, where required, the free-sale or marketing authorisation certificate from the country of manufacture.

Registration, Dossier & Tender Support

Documents for Ascorbic Acid Injection 500mg/5mL are issued by Sinophare Bio-technology Co., Ltd. — DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. Keeping one legal manufacturer across the COA, the GMP certificate and the registration file avoids assessment queries later.

• CTD dossier modules 1–5 in editable and PDF form, with the finished-product and API sections cross-referenced.
• Site Master File and GMP certificate for the manufacturing workshops.
• Method validation, stability protocol and the shelf-life justification for the marketed pack.
• Answers to authority questions during assessment, handled by the regulatory contact who prepared the file.
• Tender and framework documentation, including pre-qualification questionnaires and sample logistics.

The context for Ascorbic Acid Injection 500mg/5mL is its place among vitamins, minerals and clinical nutrition products named in the WHO Model List. Listing status informs how programmes specify a product; it is not a substitute for the import licence or marketing authorisation of the destination country.

Related Vitamins & Nutrition Products

• Alpha-Lipoic Acid Injection 5ml:125mg — 5mL
• L-Carnitine Injection 2ml:500mg — 2mL
• Pyridoxine Injection 1ml:100mg — 1mL
• Glutathione Injection 3000mg — 3000mg
• Coenzyme Q10 Injection 2ml:5mg — 2mL
• Biotin Injection 5ml:500μg — 5mL

Browse the full Vitamins & Nutrition range; all Injectables; the complete product catalogue.