FOR PHARMACISTS · SCIENTIFIC COLLECTION 10.0310 monographs · 36 SOPs · 22 forms
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SOP-011 / 2.1

Powders and hard capsules

Non-sterile solid forms with controlled uniformity and exposure.

Collection and scientific editing: Stasinos Chr. SikaliasContent edition: 2.1Record editorial review date: 2026-10-14

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Procedure

  1. Verify active, diluent, shell and dosage-unit suitability. Check that dust can be handled safely.
  2. Record particle-size and powder properties where they affect blending and segregation. Volumetric filling alone does not demonstrate content.
  3. Independently verify calculations and any premix. Apply the documented dilution and blending sequence.
  4. Check cleanliness, setup and capacity of filling equipment. Record losses, unit count and residues.
  5. Perform mass checks and, where required, content-uniformity testing using suitable sampling. Equal mass does not imply equal active content.
  6. Select moisture/light protection from evidence. Reconcile prepared, tested, rejected and supplied units.

Additional detail

Independently check total API, unit count and API/diluent ratio. Do not derive fill quantity solely from generic bulk density; establish suitability for the actual powder and capsule. Provide content-uniformity testing for low-dose or other cases required by the monograph. Do not correct mass differences with arbitrary API additions.

QC distinguishes mass uniformity, assay and content uniformity. Applicable monograph and risk determine the test and frequency; weighing ten capsules is not a universal substitute.

Stop criterion

Inadequate uniformity or unreliable weighing/containment: stop.

Related forms

F-003, F-005

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 defaults2026-10-14
  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 revision2026-10-14
  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 certification2026-10-14