- Dosage: Dobutamine 25mg
- Volume: 2 ml Ampoule
- Packaging: 2 ml ampoule * 10/tray/box*300 carton
- Shelf Life: 36 months
Package:
Product Description
Product Overview
Dobutamine Injection 12.5mg/mL is a sterile, concentrated aqueous solution of dobutamine hydrochloride intended for intravenous infusion after appropriate dilution. Each 2mL ampoule contains dobutamine hydrochloride equivalent to 25mg of dobutamine at a concentration of 12.5mg/mL. Dobutamine is a synthetic catecholamine that acts as a relatively selective beta-1 adrenergic receptor agonist, producing positive inotropic effects on the heart with relatively less chronotropic and peripheral vasoactive activity compared to other catecholamines such as dopamine or isoproterenol.
Dobutamine Injection 12.5mg/mL 2mL: 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 Dobutamine Injection 12.5mg/mL 2mL is quoted, we confirm the monograph, the strength on the artwork and the release testing required by your market — the points summarised here.
- 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)
- 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)
Each point above is reproduced because it has a practical consequence for Dobutamine Injection 12.5mg/mL 2mL: the strength you can register, the pack you can release, or the wording permitted on the label. Your national prescribing information always takes precedence.
Dobutamine Injection 12.5mg/mL 2mL — Supply Parameters
| Product Name | Dobutamine Injection |
| Specification | 12.5mg/mL, 2mL ampoule (25mg total per ampoule) |
| Dosage Form | Sterile Concentrated Solution for Intravenous Infusion (after dilution) |
| Active Ingredient | Dobutamine (as Dobutamine Hydrochloride) |
| Pharmacological Class | Synthetic Catecholamine / Beta-1 Adrenergic Receptor Agonist (Positive Inotrope) |
| Route of Administration | Intravenous infusion only (after dilution). NOT for direct intravenous injection or bolus administration. |
| Storage | Store below 25°C, protected from light. Do not freeze. Keep ampoule in outer carton until use. |
| 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, Diphenhydramine Injection 50mg/mL 2mL, Dexamethasone Injection 8mg/2mL, Acetylcysteine Injection 1g/5mL, Phentolamine Injection 10mg/1mL.
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.
Release testing for Dobutamine Injection 12.5mg/mL 2mL 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.
A typical release panel for this presentation covers:
- 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
- Testing for packaging integrity and seal testing
COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.
Packaging, Labelling & Export
- Pack size: 2mL 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: 36 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
The legal manufacturer named on every document for Dobutamine Injection 12.5mg/mL 2mL 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.
- 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.
- 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.
Dobutamine Injection 12.5mg/mL 2mL 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.
Frequently Asked Questions
What pack size is available for Dobutamine Injection 12.5mg/mL 2mL?
Standard commercial packaging for this line is 2mL amber glass ampoule. Alternative pack sizes are produced to your specification and are supported by the corresponding stability data.
What documentation comes with a shipment of Dobutamine Injection 12.5mg/mL 2mL?
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 Dobutamine Injection 12.5mg/mL 2mL 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.
Which of these emergency medicines are on the WHO Model List?
Epinephrine (adrenaline), atropine, dexamethasone injection, calcium gluconate, acetylcysteine, furosemide and heparin appear on the Model List. Confirm current listing for every molecule against the Model List and your national essential medicines list.
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.
Related Emergency & Critical Care Products
- Nimodipine Injection 10mg/50ml — 10mg
- Heparin Sodium Injection 2mL:5000IU — 5000IU
- Citicoline Injection 2ml:250mg Ampoule — 250mg/2mL
- Aceglutamide Injection 100mg/5mL — 100mg/5mL
- Diphenhydramine Injection 50mg/mL 2mL — 50mg/mL
- Dexamethasone Injection 8mg/2mL — 8mg/2mL
Browse the full Emergency & Critical Care range; all Injectables; the complete product catalogue.
Request a Quotation for Dobutamine Injection 12.5mg/mL 2mL
Tell us the monograph, pack size and quantity required for Dobutamine Injection 12.5mg/mL 2mL 12.5mg/mL, 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.
