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Active Ingredient：Calcium Gluconate
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Content Specification：1g per 10mL single dose
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Pharmaceutical Form：Sterile clear injection solution
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Applicable Standard：International pharmacopoeia specification, hospital clinical grade
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Storage Condition：Sealed storage, protected from light and high temperature
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Product Features：Standard fixed dosage, mild and stable efficacy, high safety, suitable for daily clinical electrolyte regulation and hospital bulk reserve
Package:
Product Description
- Product Name：Calcium Gluconate Injection
- Specification：1g/10mL
- Therapeutic Category：Calcium Supplement / Electrolyte Regulating Drugs
- Core Product Positioning：Clinical electrolyte balancing and calcium supplement injection for routine and emergency use
- Indicated For：Treatment of hypocalcemia, calcium deficiency tetany, allergic diseases, magnesium intoxication rescue and adjuvant therapy for electrolyte disorders
- Usage Scenario：General wards, emergency departments, pediatrics, internal medicine and critical care units
- Applicable Clients：Global medical institutions, hospital procurement centers, pharmaceutical wholesalers and medical supply agencies
Product Overview
Calcium Gluconate Injection 1g/10mL is a safe and reliable clinical calcium supplement preparation. It effectively replenishes blood calcium, maintains normal neuromuscular excitability, relieves tetany caused by hypocalcemia, and assists in correcting human electrolyte imbalance.
Calcium Gluconate Injection 1g/10mL Injection: What the Published Guidance Says
The resuscitation, antidote and critical-care injectables that a functioning emergency department cannot run without — most of them named directly on the WHO Model List.
Before Calcium Gluconate Injection 1g/10mL Injection is quoted, we confirm the monograph, the strength on the artwork and the release testing required by your market — the points summarised here.
- Specific antidotes The Model List names calcium gluconate and acetylcysteine among specific antidotes to poisoning. Acetylcysteine is the established antidote in paracetamol overdose; calcium gluconate is also the antidote administered for magnesium sulfate overdose in obstetric care. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
- Dexamethasone is a multi-role hospital injectable Beyond allergy, the Model List carries dexamethasone injection in the antiemetic section, where it appears alongside metoclopramide and ondansetron. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
- Anaphylaxis and acute allergy The Model List places epinephrine (adrenaline) among the medicines used in anaphylaxis, and carries dexamethasone injection 4 mg/mL in 1 mL ampoule as disodium phosphate salt for both antiallergic use and palliative care, as well as in the antiemetic section. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
These points are quoted because they shape how Calcium Gluconate Injection 1g/10mL Injection is specified, labelled and purchased — including strength selection, pack size and the artwork wording. Confirm each one against the approved product information in your market before finalising a purchase order.
Supply & Specification Data for Calcium Gluconate Injection 1g/10mL Injection
| Therapeutic group | Emergency & Critical Care — Emergency & Critical Care |
| 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: Nimodipine Injection 10mg/50ml, Heparin Sodium Injection 2mL:5000IU, Citicoline Injection 2ml:250mg Ampoule, Aceglutamide Injection 100mg/5mL, Dobutamine Injection 12.5mg/mL 2mL, Diphenhydramine Injection 50mg/mL 2mL, Dexamethasone Injection 8mg/2mL, Acetylcysteine Injection 1g/5mL.
Testing, Monographs & Batch 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.
Calcium Gluconate Injection 1g/10mL Injection is released against the pharmacopoeial monograph named on your order (USP, EP, BP or CP). Where no monograph exists for the exact presentation, the specification is agreed with you in writing before manufacture and is attached to the certificate of analysis.
Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.
The batch record for this product normally includes:
- 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
- Testing for dissolution or release profile (solid oral forms)
- Testing for uniformity of dosage units
COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.
Pack Configuration, Artwork & Shipping Documents
- 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.
Dossier, Authority Filings & Tender Documentation
Sinophare Bio-technology Co., Ltd. holds DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. That registration identifies the legal manufacturer on the certificate of analysis, the GMP certificate and the documents filed with your national medicines authority.
- 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.
- Artwork and mock-up approval pack, showing the carton, label and leaflet exactly as they will be printed for your market.
This page describes Calcium Gluconate Injection 1g/10mL Injection as a product of the emergency and critical-care injectables named in the WHO Model List family. A WHO or national listing is a supply-context fact, not an approval in your market; marketing authorisation remains specific to each country.
Buyer Questions about Calcium Gluconate Injection 1g/10mL Injection
How is Calcium Gluconate Injection 1g/10mL Injection 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 Calcium Gluconate Injection 1g/10mL Injection?
Each batch ships with a certificate of analysis covering description, identification, assay and related substances, plus stability data for the marketed pack and the GMP certificate of the manufacturing site. Shelf life: 36 months.
Does the batch documentation for Calcium Gluconate Injection 1g/10mL Injection support a registration filing?
Each batch ships with a certificate of analysis covering description, identification, assay and related substances, plus stability data for the marketed pack and the GMP certificate of the manufacturing site. 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 acetylcysteine as the paracetamol antidote?
Yes. Acetylcysteine injection is available for paracetamol overdose management; the Model List names acetylcysteine among specific antidotes.
Can you supply calcium gluconate for magnesium sulfate overdose?
Yes. Calcium gluconate injection is supplied both as an electrolyte replacement and as the antidote used when magnesium sulfate toxicity occurs.
Other Emergency & Critical Care Products in This Range
- Nimodipine Injection 10mg/50ml — 10mg
- Heparin Sodium Injection 2mL:5000IU — 5000IU
- Citicoline Injection 2ml:250mg Ampoule — 250mg/2mL
- Aceglutamide Injection 100mg/5mL — 100mg/5mL
- Dobutamine Injection 12.5mg/mL 2mL — 12.5mg/mL
- Diphenhydramine Injection 50mg/mL 2mL — 50mg/mL
Browse the full Emergency & Critical Care range; all Injectables; the complete product catalogue.
Request a Quotation for Calcium Gluconate Injection 1g/10mL Injection
Send the specification, pack size, quantity and destination market for Calcium Gluconate Injection 1g/10mL Injection 1g/10mL and we will confirm availability, lead time and documentation. Tender quantities and registration samples are handled on the same quotation.
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.
