FOR PHARMACISTS · REFERENCE EDITION 8.0261 monographs · 32 SOPs · 18 forms
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SOP-009 / SOP v2.0

Oral solutions, syrups and suspensions

Non-sterile oral liquids under a specifically approved master record.

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Procedure

  1. Check solubility or the need for suspension, patient suitability of excipients and the exact active-substance form.
  2. Verify water and vehicle quality. Sugar or preservative presence alone does not establish microbiological stability.
  3. Follow the specific dissolution, wetting and dispersion sequence. Record temperature, time and mixing; do not transfer settings from another product.
  4. Clarify whether the source requires final mass, final volume or addition of a specified vehicle. Check temperature before final volumetric adjustment where relevant.
  5. Apply suitable appearance, pH, yield, redispersibility and uniformity checks. Observations do not replace required quantitative analysis.
  6. Check container and dosing-device compatibility. Shaking instructions must reflect demonstrated redispersibility and be understandable to the user.

Edition-specific detail

Verify mg/mL and the exact starting tablet or bulk-material form. Modified-release or enteric-coated products cannot arbitrarily replace the specified starting material. For suspensions establish justified shaking and a suitable oral syringe; assess redispersibility after representative standing, not only immediately after mixing.

Stop criterion

Irreversible settling, separation, unsupported BUD or uncertain final strength: quarantine.

Related forms

F-003, F-005, F-006

Sources and references

  1. NAPRA — Model Standards for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 4–9Risk, personnel, facilities and QA; its historical BUD table is not used for current USP defaults2026-09-12
  2. NAPRA — Guidance Document for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 5, 6 and 7; master/batch records, delivery, qualityQuality-system implementation; historical BUD table not substituted for 2022 USP revision2026-09-12
  3. PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12