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Active Ingredient：Atropine Sulphate
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Content Specification：1mg per dose
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Pharmaceutical Form：Sterile Injection Solution
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Applicable Standard：International General Pharmacopoeia Standard / Hospital Grade Standard
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Storage Condition：Sealed, cool and dry place, protected from light
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Product Features：Standard unit dosage, easy for clinical rapid administration, stable quality, suitable for long-term medical reserve
Package:
Product Description
- Product Name：Atropine Sulphate Injection
- Specification：1mg per unit
- Therapeutic Category：Anticholinergic Drugs / Emergency Resuscitation Drugs
- Core Efficacy Positioning：Systemic anticholinergic action for clinical emergency rescue
- Indicated For：Bradycardia, Organophosphate Poisoning Resuscitation, Pre-anesthesia Medication, Smooth Muscle Spasm Relief
- Usage Scenario：Hospital emergency department, ICU, operating room, pre-hospital emergency rescue, medical institution routine reserve
- Applicable Clients：Global hospitals, emergency medical institutions, pharmaceutical distributors, medical procurement organizations
Product Overview
Atropine Sulphate Injection 1mg is a classic high-efficiency anticholinergic emergency drug for clinical professional use. It exerts comprehensive parasympathetic nerve blocking effects, effectively relieving smooth muscle spasm, inhibiting gland secretion, improving sinus bradycardia and atrioventricular block, and serving as a core first-line rescue drug for organophosphorus pesticide poisoning.
Atropine Sulphate Injection 1mg: 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.
Atropine Sulphate Injection 1mg sits in the Emergency & Critical Care range. The notes below are the ones that most often change a specification, a label or a tender submission.
- 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)
- 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)
- Pre-operative and emergency antimuscarinics Atropine appears twice on the Model List — as a pre-operative medication at 400 micrograms/mL and 1 mg/mL (sulfate) in 1 mL ampoule or vial, and among specific antidotes. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
Each point above is reproduced because it has a practical consequence for Atropine Sulphate Injection 1mg: the strength you can register, the pack you can release, or the wording permitted on the label. Your national prescribing information always takes precedence.
Supply & Specification Data for Atropine Sulphate Injection 1mg
| 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.
Release testing for Atropine Sulphate Injection 1mg 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 batch record for this product normally includes:
- 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)
- Testing for heavy metals and elemental impurities
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
The legal manufacturer named on every document for Atropine Sulphate Injection 1mg 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.
- Artwork and mock-up approval pack, showing the carton, label and leaflet exactly as they will be printed for your market.
- Batch manufacturing and packaging records released for inspection on request during supplier audits.
- 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.
Atropine Sulphate Injection 1mg is presented here against emergency and critical-care injectables 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.
Buyer Questions about Atropine Sulphate Injection 1mg
How is Atropine Sulphate Injection 1mg 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 Atropine Sulphate Injection 1mg?
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 Atropine Sulphate Injection 1mg 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 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 Atropine Sulphate Injection 1mg
Tell us the monograph, pack size and quantity required for Atropine Sulphate Injection 1mg 1mg, 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.
