Polysorbate 80 evaluation | Kemaix T-80

Polysorbate 80 Supplier for Food and Pharmaceutical Evaluation

Evaluate Kemaix T-80 using its chemical identity, a labeled batch COA example, and a document and formulation checklist.

This guide separates general food and pharmaceutical application context from evidence for the offered grade. It does not claim that Kemaix T-80 currently meets a food-additive or pharmacopoeial standard.

Chemical identity

What Polysorbate 80 Is and What HLB 15 Tells You

Kemaix T-80 is a nonionic surfactant identified in its SDS as sorbitan monooleate ethoxylate, CAS 9005-65-6. Polysorbate 80 is the product name used in the supplied documents. Tween 80 is a market and formulation search term, not a separate Kemaix grade.

The Kemaix series catalog lists an HLB value of 15 for T-80. HLB is an initial selection tool for matching surfactants with an oil phase. A value of 15 supports evaluation in oil-in-water systems and comparison with lower-HLB surfactants.

HLB does not prove that an emulsion will remain stable. It also does not establish a permitted use, compliance status, dosage, or route of administration. The oil phase, active ingredients, pH, temperature, processing conditions, and target shelf life can all change the result. Treat HLB 15 as a screening reference. Confirm the offered material through its current SDS and COA, then test it in the intended formulation.

Application context

Where Polysorbate 80 Fits in Food and Pharmaceutical Formulation Work

Polysorbate 80 may enter a formulation screen when the technical objective involves oil-in-water emulsification, solubilization, wetting, or suspension support. These are formulation roles. They are not evidence that every Polysorbate 80 grade is approved for every food or pharmaceutical use.

Oil-in-water emulsification

HLB 15 makes T-80 a candidate for initial screening where an oil phase must be dispersed in water. Define the required HLB, select a starting concentration, and monitor separation, droplet behavior, viscosity, and appearance.

Solubilization and wetting

Evaluate compatibility with the active, other excipients, salts, preservatives, pH, and temperature. Do not transfer a result from an unrelated formula.

Food and pharmaceutical context

For food work, identify the country, food category, technical effect, and proposed use level. For pharmaceutical work, specify the country, route, dosage form, and required monograph or internal specification.

The current Kemaix file set does not establish a food-additive standard, pharmacopoeial grade, or suitability for injection. Do not infer those claims from the name Polysorbate 80, an HLB value, an SDS, or a batch COA.

Confirmed product data

Confirmed Kemaix T-80 Data and One Current Batch Example

The SDS identifies the substance and gives storage and transport information. The series catalog provides general reference values. The COA records results and acceptance limits for one batch. Keep these sources separate when setting purchasing requirements.

Batch example: 20260329-09, dated March 29, 2026. These results are not a universal guarantee for every shipment.

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Kemaix T-80 batch results and acceptance specifications
Item Batch result Acceptance specification Source
Appearance Yellow viscous liquid Yellow viscous liquid COA, batch 20260329-09
pH, 1% solution 6.29 5.0-7.0 COA, batch 20260329-09
Acid value 0.55 mgKOH/g <=2.0 mgKOH/g COA, batch 20260329-09
Moisture 1.25% <=2.0% COA, batch 20260329-09
Saponification value 47.81 mgKOH/g 43-55 mgKOH/g COA, batch 20260329-09
Hydroxyl value 81.02 mgKOH/g 65-90 mgKOH/g COA, batch 20260329-09
Color 4.7 Gardner <=8.0 Gardner COA, batch 20260329-09

The SDS lists sorbitan monooleate ethoxylate at >=97.5% and CAS 9005-65-6. It states 24 months for unopened material under normal temperature conditions and instructs users to keep the container tightly closed in a cool, dry, ventilated place. ADR/RID, IMDG, and IATA are listed as not dangerous goods.

The catalog separately lists amber viscous liquid, HLB 15, specific gravity 1.06-1.09, hydroxyl value 60-85 mgKOH/g, saponification value 40-50 mgKOH/g, acid value <=2.0 mgKOH/g, and moisture <=3%. The catalog and batch COA ranges are not identical. Do not merge them. Request the current quotation documents and agreed acceptance specification.

Approval boundary

Do Not Treat the Product Name as Proof of Food or Pharmaceutical Grade

Product identity answers what the substance is. Grade documents show whether the offered material is controlled against a specific standard. Formulation tests show whether that material works in your system. Treat these as three separate approval gates.

The current Kemaix library contains a T-80 SDS, a series catalog, and a batch COA. Those files do not, by themselves, establish compliance with USP-NF, Ph. Eur., E433/INS 433, Halal, Kosher, another food or pharmaceutical requirement, or suitability for injection.

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Confirmed, document-gated and test-required evidence matrix
Confirmed for Kemaix T-80 Confirm for the intended market Test in the formulation
Trade name T-80 Destination country and applicable regulation Appearance and homogeneity
Sorbitan monooleate ethoxylate Food category and permitted technical effect Separation or sedimentation
CAS 9005-65-6 Proposed use level Turbidity or clarity
Nonionic surfactant identity Pharmaceutical route and dosage form Viscosity response
SDS composition >=97.5% Required monograph and current grade documents Compatibility with actives and excipients
HLB 15 catalog reference Buyer specification and batch release requirements Stability under selected temperature and time conditions
Batch-example COA results Packaging, labeling, and destination requirements Repeatability before scale-up

For food work, send the intended country, food category, technical purpose, and target use level. For pharmaceutical work, send the route, dosage form, applicable monograph, and exact tests or limits your quality team requires. Kemaix can then check the offered grade and current documents. Your quality or regulatory team must compare those documents with the destination-market requirement.

Reference context: the USP Polysorbate 80 definition describes the compendial identity, while the FDA Inactive Ingredient Database guidance separates route and dosage form. Neither source certifies Kemaix T-80.

Formulation validation

Run a Controlled Formulation Screen Before Scale-Up

Use the free 200-500 g sample to compare T-80 under controlled conditions. Your formulation or technical team must define the test design and acceptance endpoints because Kemaix product documents do not guarantee finished-formula performance.

  1. Define the baseline. Record the oil phase, active ingredients, other surfactants or excipients, pH, processing temperature, mixing sequence, mixing energy, target storage conditions, and required HLB basis.
  2. Screen a dose ladder. Keep the base formula and process constant while changing only T-80. Include a control and multiple levels around the technical team’s starting point.
  3. Stress the system. Apply relevant temperatures, hold times, agitation, dilution, or other process conditions. Select observations such as appearance, separation, turbidity, viscosity, sedimentation, or active compatibility.
  4. Confirm repeatability. Repeat the preferred condition, compare neighboring dose levels, and confirm the result with the batch intended for approval before scale-up.

Document the sample grade code and batch reference throughout the trial. If you compare T-80 with another surfactant or a blend, keep the total surfactant basis clear. Share the application and acceptance criteria when requesting documents.

Procurement controls

Align the Quote, Sample and Batch Documents

Link the laboratory trial to the purchase order by using the same product identity and acceptance requirements. Send Kemaix the following information before requesting a quote:

  • Product name and grade code, including T-80
  • Destination country and intended application
  • Required standard, monograph, or internal specification
  • Requested SDS, current COA, and other approval documents
  • Sample grade code and batch identity
  • Required quantity, packaging, labeling, destination, and schedule

Kemaix offers a free 200-500 g sample for evaluation. The general MOQ for standard products is 200 kg. Stock, product-specific packaging, and lead time are confirmed per inquiry. Do not apply a package format or delivery schedule from another surfactant to T-80.

Reference the approved grade and agreed acceptance specification on the purchase order. Do not combine ranges from different sources into one limit set.

Evaluation FAQ

Polysorbate 80 Evaluation FAQ and Sample Request

Is T-80 the same as Polysorbate 80 or Tween 80?

Kemaix uses T-80 as the trade name for its Polysorbate 80 product. The SDS identifies sorbitan monooleate ethoxylate, CAS 9005-65-6. Tween 80 is a market and formulation term, not a separate Kemaix grade name in the supplied documents.

What does HLB 15 mean for formulation selection?

Use HLB 15 as an initial indicator when screening an oil-in-water system or comparing surfactants. It does not guarantee stability, compatibility, permitted use, or a finished-product result.

Is Kemaix T-80 automatically food grade or pharmaceutical grade?

No. The current file set contains an SDS, series catalog, and batch COA. These do not establish USP-NF, Ph. Eur., E433/INS 433, injectable, Halal, Kosher, or another grade-specific status.

Can I request a sample, and what is the MOQ?

Kemaix offers a free 200-500 g sample. The general MOQ for standard products is 200 kg. Stock, packaging, and lead time are confirmed for each inquiry.

What information should I send with my inquiry?

Include the destination country, application, food category or pharmaceutical route and dosage form, proposed use level, required standard, specification limits, quantity, packaging requirements, and requested schedule.

After receiving the inquiry, Kemaix will check the offered T-80 grade, current SDS and COA, sample availability, packaging options, stock, and lead time.

Picture of Grace Dou

Grace Dou

Grace Dou is a technical content reviewer at Nanjing Kemaix Advanced Materials Co., Ltd., focusing on EO/PO derivatives, nonionic surfactants, formulation scope, test conditions and documentation boundaries. Final grade selection should use current specifications and finished-formula testing.

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