Specification & Composition
– Active Ingredient：Magnesium Sulphate
– Concentration：10% w/v
– Packaging：10mL glass ampoule
– Compliance Standard：BP (British Pharmacopoeia)
– Storage Condition：Shade, sealed, dry environment
– Shelf Life：Standard pharmaceutical validity period
Package:
Product Description
– Product Name：Magnesium Sulphate Injection BP
– Concentration：10%
– Specification：10mL per ampoule
– Standard：British Pharmacopoeia (BP)
– Therapeutic Category：Anticonvulsants / Obstetric Emergency Drugs
– Indicated For：Eclampsia, Preeclampsia, Seizure Prophylaxis in Pregnancy- Usage Scenario：Hospital, Clinic, Obstetric Department Emergency Use
Product Overview
Magnesium Sulphate 10% 10mL BP injection is a high-purity hospital-grade anticonvulsant drug formulated in accordance with British Pharmacopoeia standards. It is widely applied in obstetric clinical settings, mainly used for the prevention and treatment of convulsions caused by preeclampsia and eclampsia in pregnant women. The fixed 10% concentration and 10mL independent ampoule specification ensures accurate dosage, convenient clinical operation, and stable drug efficacy, meeting the emergency medication needs of global hospital obstetric departments.
Magnesium Sulphate BP 10% 10mL: What the Published Guidance Says
The obstetric emergency medicines and newborn-care antiseptics that sit on the WHO Model List — supplied with the labelling discipline these products demand.
This page collects the supply-relevant facts for Magnesium Sulphate BP 10% 10mL — specification, testing, packaging and the registration paperwork that travels with the batch.
- MSF's own warning: check the ampoule strength Because magnesium sulfate is supplied in several strengths, MSF explicitly instructs users to check the strength of the ampoule carefully before use, noting that 1 g ampoules exist alongside the 5 g presentation it describes. MSF Essential Drugs — Magnesium sulfate injectable
- Magnesium sulfate is the anticonvulsant for pre-eclampsia and eclampsia MSF lists magnesium sulfate injectable for severe pre-eclampsia (prevention of eclamptic seizures) and for eclampsia (treatment of seizures and prevention of recurrence), describing it as a calcium antagonist and anticonvulsant. The Model List also carries magnesium sulfate among antiseizure medicines. MSF Essential Drugs — Magnesium sulfate injectable
- Monitoring and the antidote Patellar reflex, blood pressure, heart and respiratory rate are checked every 15 minutes during the first hour, then hourly, with urine output checked hourly. If signs of overdose appear, magnesium sulfate is stopped and 1 g calcium gluconate given by slow intravenous injection as the antidote. MSF also notes magnesium sulfate should not be combined with nifedipine. MSF Essential Drugs — Magnesium sulfate injectable
Each point above is reproduced because it has a practical consequence for Magnesium Sulphate BP 10% 10mL: the strength you can register, the pack you can release, or the wording permitted on the label. Your national prescribing information always takes precedence.
Ordering Parameters for Magnesium Sulphate BP 10% 10mL
| Therapeutic group | Maternal & Newborn — Maternal & Newborn |
| Manufacturer | Sinophare Bio-technology Co., Ltd. (GMP, China) |
| Documentation supplied | COA, HPLC/GC data, stability data, dossier package |
The same therapeutic range is supplied in several presentations, so one purchase order can cover a mixed requirement: hCG Injection 5000 IU, Metronidazole Suppository 500mg, Chlorhexidine Acetate Suppository 20mg, Erythromycin Suppositories 100mg, Martrine Suppository 50mg, Progesterone Suppository 25mg, Clotrimazole Vaginal Suppositories 150mg.
Pharmacopoeial Standard, Release Testing & COA
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.
Release testing for Magnesium Sulphate BP 10% 10mL follows the monograph you nominate — USP, EP, BP or CP. If the presentation is not covered by a monograph, the specification is frozen in writing with your quality team before the batch is manufactured.
Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.
The quality control package for the marketed pack covers:
- Testing for microbial limits and preservative efficacy (multi-dose presentations)
- Testing for heavy metals and elemental impurities
- Testing for packaging integrity and seal testing
- Testing for description and identification
- Testing for assay of the active substance
- Testing for related substances and impurities
COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.
Packing, Labelling Languages & Export Paperwork
- Shelf life: 36 months (unopened). Stability data for the marketed pack is included in the dossier.
- Labelling: we typeset the carton and leaflet in English, Arabic, French, Russian and Spanish and in any further language your market requires, carrying your own brand where the local rules allow.
- Export: commercial invoice, packing list, certificate of origin, GMP certificate, COA and the free-sale certificate issued by the country of manufacture whenever your customs or regulator asks for it.
Marketing Authorisation & Tender Support
The legal manufacturer named on every document for Magnesium Sulphate BP 10% 10mL is Sinophare Bio-technology Co., Ltd., DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. The same entity appears on the GMP certificate and on the dossier submitted to your regulator.
- Re-test or renewal support when the marketing authorisation comes up for variation or renewal.
- 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.
Magnesium Sulphate BP 10% 10mL is presented here against obstetric and newborn-care medicines named in the WHO Model List. Inclusion in an essential-medicines list does not authorise sale in any particular country — the marketing authorisation for that market is a separate step.
Magnesium Sulphate BP 10% 10mL: Common Procurement Questions
How is Magnesium Sulphate BP 10% 10mL packaged?
Injection presentations are quoted to your pack specification, with the artwork, pack size and labelling language confirmed before manufacture.
What documentation comes with a shipment of Magnesium Sulphate BP 10% 10mL?
The documentation set for every shipment includes the certificate of analysis (description, identification, assay, related substances), stability data for the marketed pack, and the site GMP certificate. Shelf life: 36 months.
Does the batch documentation for Magnesium Sulphate BP 10% 10mL support a registration filing?
The documentation set for every shipment includes the certificate of analysis (description, identification, assay, related substances), stability data for the marketed pack, and the site GMP certificate. Shelf life: 36 months. The full CTD dossier and the authority assessment file are supplied as part of a registration order; routine shipments carry the COA and stability data only.
Do you supply calcium gluconate as the magnesium sulfate antidote?
Yes. Calcium gluconate injection is part of our emergency and critical-care range and pairs with magnesium sulfate in obstetric emergency kits.
Do you supply magnesium sulfate in the strengths used in obstetric protocols?
Yes. We supply magnesium sulfate injection and will mark the ampoule strength prominently, because MSF explicitly warns users to check the ampoule strength before use.
Products Commonly Ordered with Magnesium Sulphate BP 10% 10mL
- hCG Injection 5000 IU — 5000IU
- Metronidazole Suppository 500mg — 500mg
- Chlorhexidine Acetate Suppository 20mg — 20mg
- Erythromycin Suppositories 100mg — 100mg
- Martrine Suppository 50mg — 50mg
- Progesterone Suppository 25mg — 25mg
Browse the full Maternal & Newborn range; all Injectables; the complete product catalogue.
Request a Quotation for Magnesium Sulphate BP 10% 10mL
Tell us the monograph, pack size and quantity required for Magnesium Sulphate BP 10% 10mL 10mL, together with the destination market, and the quotation will state lead time and the documents that ship with the batch. Samples for registration can be added to the same order.
Sources & Regulatory Notes
Reference information only. The published guidance summarised on this page is quoted for professional and regulatory-context purposes and does not constitute medical advice, a prescribing recommendation or a promotion of any product for a particular indication. Prescribing decisions must follow the approved product information and national treatment guidelines in the market of use.
