Stasinos Chr. Sikalias · The science of compounding

White Ointment JP

CGR-JP-005 · MHLW — JP XVIII: White Ointment JP

For local reviewCGR-JP-005Japan

Documented bibliographic addition; requires local scientific approval before use as a master formulation record.

Dosage formCutaneous ointment / ointment base
Reference batch1000 g
Monograph version5.0
Source packagev5

Source formula

IngredientSource quantity
White beeswax50 g
Sorbitan sesquioleate20 g
White petrolatumq.s. ad 1000 g

Quantities refer to the source batch. This website does not automatically scale formulas, assign doses or calculate BUD.

Description

Documented in source

White ointment with a slight characteristic odour.

References: [1]

Use and action

Partial evidence

Lipophilic ointment base. JP specifies it as the base of Zinc Oxide Ointment. This monograph does not provide an independent therapeutic indication or dose.

References: [1]

Specifications

Documented in source

White appearance, slight characteristic odour and viscosity suitable for cutaneous application under JP 11-4. No numerical viscosity limit, pH or product-specific assay is given.

References: [1]

Light

Not established

No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

References: [1]

Air

Not established

No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

References: [1]

Water and solubility

Not established

No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

References: [1]

Humidity

Not established

No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

References: [1]

Temperature

Not established

No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

References: [1]

pH and related incompatibilities

Not established

No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

References: [1]

Other incompatibilities

Not established

No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

References: [1]

Ingredient-specific information

Partial evidence

Exact identities: Λευκός κηρός μελισσών / White beeswax; Σεσκιελαϊκός εστέρας σορβιτάνης / Sorbitan sesquioleate; Λευκή βαζελίνη / White petrolatum. Use pharmacopoeial raw materials of the referenced edition, with CoA verification. Do not arbitrarily change salt, hydration state or strength. Record the actual q.s. amount in the batch.

References: [1]

Compounding conditions

Editorial checklist

JP provides no specific numerical room limits for this formula. Define a local SOP covering suitable clean conditions, temperature control and contamination prevention. This is an editorial checklist.

References: [1] · [2]

Personal protective equipment

Partial evidence

Clean protective clothing and head covering under AEMPS PN/L/PG/002/00. Use suitable gloves where contact is possible and respiratory/eye protection where powder handling requires it. Exact glove material, ventilation and respiratory protection must follow the SDS and local exposure assessment.

References: [4]

Risks and precautions

Partial evidence

Base without a medicinal active. Local assessment includes hot melt, burns, ingredient allergy and contamination risk. No potent-drug classification has been established.

References: [1]

BUD rationale

Not established

The specific monograph provides no finished-product beyond-use period/BUD. No duration is assigned by assumption. Suitable stability evidence and responsible-pharmacist approval are required before release.

References: [1]

Bases and dependencies

Documented in source

No separate compound base is required in the explicit formula.

References: [1]

Equipment

Editorial checklist

Balance with suitable resolution, mortar/spatula, suitable mixing vessels and final container. Add volumetric equipment for mL, a controlled water bath where melting is specified and a suitable filter where required. Analytical equipment follows the QC methods.

References: [1] · [2]

Preparation procedure

Partial evidence

1. Weigh the ingredients; theoretical white petrolatum is 930 g.
2. Melt and mix the lipophilic base components by controlled warming under JP 11-4.
3. Mix/knead until homogeneous. The local SOP must define the exact temperature, time and mixing speed; the monograph does not provide them.

References: [1] · [2]

Observations

Partial evidence

Original bilingual rendering of the formula and specifications. This base differs from Simple Ointment BP, USP White Ointment and plain petrolatum.

References: [1]

Packaging

Partial evidence

Tight container. No specific container material is prescribed.

References: [1]

Labelling

editorial_specimen

White Ointment JP
Quantity: _____ · Batch: _____ · Prepared: _____ · Use by: _____
External use only. Storage: Keep tightly closed. No specific temperature or light protection is prescribed for the finished product.
Patient/directions or laboratory use: _____ · Pharmacy/telephone: _____
Specimen for pharmacist adaptation; not a final approved label.

References: [1]

Quality control

Partial evidence

Check appearance, odour and suitable consistency under the monograph/JP 11-4. Final mass and homogeneity are proposed local process checks. They do not replace overall JP conformity or establish a beyond-use period.

References: [1] · [2]

Storage

Partial evidence

Keep tightly closed. No specific temperature or light protection is prescribed for the finished product.

References: [1]

Dispensing and directions

Partial evidence

Intended for pharmaceutical use as a base. Adding an active requires compatibility assessment and separate evidence for the finished preparation.

References: [1]

Sources and traceability

  1. MHLW — JP XVIII: White Ointment JP

    2021 · JP XVIII (2021), printed p. 1921; General Rules for Preparations 11-4, p. 20 · A1 official pharmacopoeia

    Review date reported in supplied metadata: 2026-09-10

  2. MHLW — JP XVIII, General Rules for Preparations

    2021 · 11-4 Ointments and 11-2 Cutaneous liquids, printed p. 20; Other Preparations 3 Spirits, p. 22; General Notices · A1 official pharmacopoeia

    Review date reported in supplied metadata: 2026-09-10

  3. PN/L/FF/006/00 ELABORACIÓN DE POMADAS

    PN/L/FF/006/00 · §4.3 environment; §4.4 method; §4.6 controls · A2 official technical guidance

    Review date reported in supplied metadata: 2026-09-10

  4. PN/L/PG/002/00 INDUMENTARIA

    PN/L/PG/002/00 · Clothing and protective equipment · A2 official technical guidance

    Review date reported in supplied metadata: 2026-09-10

  5. AEMPS — Aviso legal

    Policy checked 2026-09-10 · Reuse conditions · Rights policy, not clinical evidence

    Review date reported in supplied metadata: 2026-09-10

  6. BOE — Real Decreto 1495/2011, artículos 7–10 y anexo

    Policy checked 2026-09-10 · Reuse conditions · Rights policy, not clinical evidence

    Review date reported in supplied metadata: 2026-09-10

  7. MHLW — Copyright and Public Data License policy

    Policy checked 2026-09-10 · Reuse conditions · Rights policy, not clinical evidence

    Review date reported in supplied metadata: 2026-09-10

  8. Digital Agency — Public Data License 1.0

    Policy checked 2026-09-10 · Reuse conditions · Rights policy, not clinical evidence

    Review date reported in supplied metadata: 2026-09-10

  9. PMDA — JP XVIII supplements and errata index

    Supplement I 2022; II 2024; base errata March 2026 · Selected entries checked; no change to these four compositions identified · A1 official edition control

    Review date reported in supplied metadata: 2026-09-10

Provenance and reuse

Source: Ministry of Health, Labour and Welfare, Japan, Japanese Pharmacopoeia XVIII, English edition 2021. Reuse under Public Data License 1.0 through the MHLW policy, with source attribution and changes identified. Greek translation, English summary/restructuring and editorial additions: Greek Formulary Sikalias, Stasinos Chr. Sikalias, compounding.gr. This is not an official translation or MHLW endorsement. The Japanese original prevails if it differs from the official English rendering. No logos or specially restricted third-party material are used. Supplementary AEMPS/CDC information is attributed separately.

SHA-256 of the supplied PDF: 41fde177485bcc37f07dcb8e9f3b8be948ab3f3aec749389dc3e775532a5fb66