Paracetamol Infusion 1g/100ml GMP Certified IV Injection

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Overview

Paracetamol Infusion 1g/100ml is a professional intravenous analgesic and antipyretic drug. It is widely applied in modern hospitals for rapid relief of moderate to severe pain and effective fever reduction.

As a classic and safe clinical infusion, it features fast absorption, stable efficacy and high safety, ideal for postoperative care, emergency treatment and general inpatient departments.

Specification

  • Product Name: Paracetamol Infusion
  • Standard Dosage: 1g / 100ml per bag
  • Administration: Intravenous drip
  • Certificate: GMP Certified
  • Storage: Room temperature sealed storage

Main Functions & Indications

It is indicated for the relief of moderate to severe pain and the treatment of fever in adults and adolescents, especially when oral medication is not available or ineffective.

Common usage scenarios:

  • Postoperative pain relief
  • Trauma and surgical pain
  • Clinical fever reduction
  • Emergency department routine medication

Product Advantages

✅ Standard 1g/100ml fixed specification, easy for clinical dosing

✅ Fast acting by intravenous infusion, quick pain and fever relief

✅ Strict GMP production, stable batch quality

✅ Mild formula, low adverse reaction rate

✅ Complete documentation for international registration and tender

✅ Support OEM packaging & private label service

Our Service

We provide stable bulk supply of Paracetamol Infusion 1g/100ml with competitive factory price.

Customized packaging, logo design and registration document support are available for global pharmaceutical distributors, hospital suppliers and medical agents.

Why the infusion form is specified separately

Paracetamol is usually bought as a tablet or an oral liquid, so the intravenous presentation is often treated as a variant of the same line item. It is not. The infusion is a sterile parenteral product: it needs aseptic filling, a container-closure system with a validated integrity test, and a release panel that includes sterility, bacterial endotoxin and visible particulates. In a hospital setting it also has to be compatible with the giving set and the co-administered fluids on the same ward.

What the published guidance specifies

  • The Model List specifies the exact presentations Section 2.1 of the 24th WHO Model List (2025) lists acetylsalicylic acid (suppository 50–150 mg; tablet 100–500 mg), ibuprofen (oral liquid 100 mg/5 mL; tablet 200, 400 and 600 mg) and paracetamol (oral liquid 120 mg/5 mL or 125 mg/5 mL and 250 mg/5 mL; suppository 100 and 250 mg; tablet 250, 325 and 500 mg; dispersible tablet 100 and 250 mg). WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
  • Paracetamol is an antipyretic and analgesic — not an anti-inflammatory The Model List carries a footnote stating paracetamol is not recommended for anti-inflammatory use due to lack of proven benefit to that effect. Marketing copy that positions paracetamol as an anti-inflammatory is inconsistent with the WHO listing. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
  • Paracetamol is an antipyretic and analgesic, not an anti-inflammatory. The Model List carries a footnote stating paracetamol is not recommended for anti-inflammatory use because benefit in that indication is not proven. Promotional copy that positions it as an anti-inflammatory is both inaccurate and, in most markets, non-compliant. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
  • Presentation discipline is a safety issue. The same Model List warns that carrying two near-identical oral-liquid strengths on one market causes prescribing and dispensing errors — the reasoning that also drives the caution around high-strength intravenous paracetamol and infusion-rate errors in paediatric practice.

Specification and release testing

The product is manufactured to a written specification naming the assay method and the limits applied. Release testing for the infusion covers:

  • Assay and identification against the nominated pharmacopoeial monograph
  • Related substances and degradation products
  • Sterility, by membrane filtration or direct inoculation as validated
  • Bacterial endotoxins, with the limit justified for the dose and route
  • Visible and sub-visible particulates
  • pH, osmolality and appearance of the solution
  • Extractable volume and container-closure integrity

Batch documentation includes the certificate of analysis, the specification, the method of analysis, stability data supporting the stated shelf life, and the sterility assurance summary covering media fills for the presentation.

Pack, presentation and logistics

  • Presentation — 1 g in 100 mL, 10 mg/mL, in glass or non-PVC bag or bottle depending on the destination market's preference.
  • Labelling — artwork in English, Arabic, French, Russian or Spanish, and in your own brand where the destination labelling rules allow it.
  • Shipping and storage — shipped with the temperature range stated, since excursion control is part of the registration commitment for a parenteral.

Registration support

For a registration order we agree in writing who files and in which market, and which of the following is supplied: CTD dossier modules 1–5, Site Master File, GMP certificate, method validation reports, stability protocol and data, and answers to authority questions during assessment. Registration samples are quoted alongside the commercial offer so the sample quantity is not a later negotiation.

Questions buyers ask

Is the infusion the same product as your paracetamol tablets?

No. They share the active substance and the specification philosophy, but the infusion is a sterile parenteral product with its own manufacturing line, container system, release panel and stability programme.

Do you supply the oral liquid strengths as well?

Yes, in weight-band paediatric presentations. Note that the WHO Model List warns against carrying two near-identical oral-liquid strengths on the same market, so we recommend and will supply a single strength per market.

What documentation comes with the batch?

Certificate of analysis, specification, method of analysis, stability data, GMP certificate, and the sterility assurance summary for the presentation.

Can you produce it under our brand?

Yes, where the destination labelling rules permit a distributor brand on a sterile product. The manufacturer statement required by those rules is agreed before the first print run.

Related pages

Analgesics & antipyretic range · Paracetamol 500 mg tablets · Paracetamol & ibuprofen API · All injectables

Reference information only. Published guidance is quoted for professional and regulatory-context purposes and is not medical advice or a prescribing recommendation.