YMC-Triart Prep. Robust Improved particle properties result in better chromatographic performance

Transcription

1 Robust and ph stable hybrid silica process material The Selectivity Company Robust Improved particle properties result in better chromatographic performance Flexible Chemical stability ph 2-10 Durable against alkaline CIP Economic Purify more endproduct on less stationary phase

2 2 Particle Technology... page 3 Physicochemical Characteristics... page 4-5 Mechanical Stability... page 6 Comparing C18-S to competitor material... page 7 Cleaning-in-place (CIP)... page 8-9 Applications... page 10 Ordering Information... page 11

3 3 With, a ph stable preparative grade HPLC stationary phase gets available. It is produced in lot sizes of up to several hundred kg. This innovative hybrid material sets a new benchmark for RP HPLC phases. It is well suited for production scale applications, as it is available up to multi-ton scale. is chemically stable up to ph This provides more flexibility for method development and allows for more efficient cleaning-in-place (CIP) procedures. From real life process development work has shown to outperform traditional silicabased materials 2- to 4-fold in terms of durability. Longer column lifetimes lead to more kilogram of product produced per kilogram of stationary phase. The results are: improved production procedures reduced overall costs Particle technology is a preparative material prepared from a well-controlled particle formation process which is adapted from micro-reactor technology. The recently developed production step results in truly narrow particle and pore size distributions! With otherwise, challenging ph and high temperature conditions are no longer a limitation even to the day-to-day work in laboratories or production. Most importantly, due to its unique particle composition, a balanced hydrophobicity and silanol activity are achieved which makes a First Choice material in method development! Robust Improved particle properties result in better chromatographic performance Flexible Chemical stability ph 2-10 Durable against alkaline CIP Economic Purify more endproduct on less stationary phase

4 4 Specification Base material C18-S inorganic/organic hybrid C8-S Particle size [µm] 10,15, 20 10, 15, 20 Pore size [nm] Specific surface area [m 2 /g] Bonding polymeric C18 polymeric C8 End-capping yes yes Flexible ph range 2.0 ~ ~ 10.0 Homogeneous and uniform particles* YMC-Triart (12 nm, 5 µm) (20 nm, 15 µm) X-Bridge HILIC ( TM of Waters Corp.) (13.5 nm, 5 µm) is produced using micro-reactor technology in the granulation process. The results are spherical particles with a highly uniform particle and pore size distribution. This leads to a reduction of the back-pressure and to more reproducibility in surface modification. * by courtesy of YMC Co., Ltd.

5 5 Excellent ph stability Acidic condition (ph 1, 70 C) Alkaline condition (ph 11.5, 50 C) (%) of initial retention The columns are stored in acetonitrile/water/tfa (10/90/1) 70 C, and the performance tested every 20 hours Time (hr) C18-S, 15 µm Kromasil C18, 16 µm (Kromasil) ODS-AP, 15 µm (Daiso) Chromatorex C18, 15 µm (Fuji) (%) of initial theoretical plate Chromatorex C18, 15 µm (Fuji) ODS-AP, 15 µm (Daiso) Kromasil C18, 16 µm, Kromasil C18-S, 15 µm Time (hr) Column: 250 x 6.0 mm ID Eluent: acetonitrile / water (60/40) Flow rate: 1.7 ml/min Temperature: 37 C Detection: UV at 254 nm Sample: butyl benzoate Column: 150 x 4.6 mm ID Eluent: 50 mm TEA in methanol / 50 mm TEA in water (ph 11.5) (20/80, v/v) Flow rate: 1.0 ml/min Detection: UV at 254 nm Sample: caffeine At high ph C18-S shows lifetimes of up to 4 times longer compared to conventional silica materials. This enables new separations at high ph which are not possible with silica material. Furthermore, the material can endure more CIP-cycles than conventional phases used in industrial processes (see page 8). Advantages of ph-stability 2-10 Chemical and mechanical stability Uniform particle size Narrow pore size distribute 100% aqueous conditions Your benefit Flexibility Method development Durable against CIP-conditions Cost savings High production throughput Improved packing = improved chromatographic performance High loadability Flexibility Method development Separation of polar substances Application Data by courtesy of YMC Co., Ltd.

6 6 Mechanical stability test Test procedure 1. Column packing Column: DAU Bed length: 100 x 50 mm ID Pressure: 6.5 MPa 2. Pressure measurement Eluent: methanol / water (85/15) Flow rate: 50 ml/min Temperature: ambient 3. Unpacking Psi/m 2000 Backpressure Less backpressure = higher throughput possible Packing number (10 µm, 20 nm) (Hybrid silica) YMC HG-series (10 µm, 20 nm) (High grade silica) Traditional Silica (10 µm, 20 nm) Shearing and crushing of silica particles leads to the formation of fines, which results in an increased backpressure. By using mechanically stable, spherical particles the formation of fines can be reduced. Here, high mechanical stability of is demonstrated by means of repeated packing of a DAC column. Even after more than 10 repacking cycles for the same material the pressure does not increase. The absence of fines is proven by a constant backpressure. This makes a valuable asset for method development and especially for process optimisation!

7 7 YMC Triart Prep C18-S vs. competitor material (client data*) Client data confirms that C18-S shows retention for hydrophobic compounds comparable to conventional silica materials. At the same time polar molecules are exceptionally well separated. * Client data shows non-optimized scouting runs performed on the respective C18 material packed into 250 x 4.6 mm ID columns. Narrow pore distribution 4500 d Vp/ d logd Conventional silica-based particle X-Bridge HILIC Pore size (nm) A narrow pore size distribution of a stationary phase beneficially affects peak width and sample loading in liquid chromatography. Where micropores account for an artificially high surface area of a stationary phase but are mostly inaccessible to target molecules, mesopores decreases the column efficiency due to a steric hindrance effect, which significantly slows mass transfer. C18-S exhibits a narrower pore size distribution with fewer micro- and mesopores. This results in improved peak shapes and higher sample loading in your preparative processes. Application Data by courtesy of YMC Co., Ltd.

8 8 Cleaning-in-place (CIP) Test procedure Sample injection (insulin in human serum) injected 20 times Regeneration with alkaline solution Wash with alkaline solution 0.1 M NaOH / acetonitrile (50/50) 10 CV Neutralisation and wash with organic solvent 1. acetonitrile / water (20/80) 2. acetonitrile / water (90/10) CIP performance of C8-S Effect of CIP with alkaline solution Durability under repeated CIP Column: C8-S (20 nm, 10 µm) 250 x 4.6 mm ID Eluent: A) water / TFA (100/0.1) B) acetonitrile / TFA (100/0.1) 28-35% B (0-15 min) Flow rate: 1.0 ml/min Temperature: 25 C Detection: UV at 220 nm Injection: 30 µl Sample: 10 mg/ml insulin bovine + human serum (2:1) Application Data by courtesy of YMC Co., Ltd.

9 9 CIP performance of C8-S C8-S (10 µm, 20 nm) Silica based C8 material (10 µm, 20 nm) Column: 50 x 4.6 mm ID Eluent: A) water / TFA (100/0.1) B) acetonitrile / TFA (100/0.1) 29-36% B (0-2 min), 36% B (2-3 min), 29% B (3-6 min) Flow rate: 1.0 ml/min Temperature: 25 C Detection: UV at 220 nm Injection: 6 µl Sample: 10 mg/ml insulin bovine + human serum (2:1) Column lifetime extended by factor > 2 In production repeated injections of a solution of insulin in human plasma/serum are carried out. Consequently, absorption of protein and other impurities to the surface of the packing material reduces the retention capacity of the column. Methodology: At this point a wash step with an alkaline solution (e.g. 0.1 M NaOH) removed the impurities and restores the full capacity of the column. Problem: Silica materials are unsuitable for alkaline wash conditions, because of their poor durability at high ph. Solution: Hybrid silica based has an excellent durability at high ph. It is amenable to alkaline wash conditions and thus enables longer column lifetime. This in turn reduces production costs: Lower consumption of packing material and fewer downtimes due to column repacking. An extension of column lifetime by a factor of > two has been achieved! Application Data by courtesy of YMC Co., Ltd.

10 10 Structurally similar peptides at ph > 7 Easy separation ph-shift Column: YMC-Pack Polymer C18, 250 x 4.6 mm ID Eluent: acetonitrile / water / TFA (18/82/0.05) (ph 2.2) Flow rate: 0.5 ml/min Detection: UV at 220 nm Injection: 10 µl Sample: 1. Angiotensin III 2. Angiotensin II 3. Angiotensin I Column: C8-S (20 nm, 10 µm) 250 x 4.6 mm ID Eluent: A) acetonitrile / 10 mm NH 4 H 2 PO 4 + NH 4 OH (50/50) (ph 2.2) B) 10 mm NH 4 H 2 PO 4 + NH 4 OH (ph 7) Gradient: 35-65% A in 25 min Flow rate: 1 ml/min Detection: UV at 215 nm Injection: 10 µl Sample: 1. Angiotensin II 2. Angiotensin III 3. Angiotensin I Methods developed on analytical YMC-Triart material are readily transferred to preparative conditions. Thus, is equally suitable for industrial scale purifications and in process controlls. Ordering information Pore size (nm) 12 C18-S Particle size (µm) Product Code Pore size (nm) C8-S Particle size (µm) Product Code 10 TAS12S11 10 TOS20S11 15 TAS12S TOS20S16 20 TAS12S21 20 TOS20S21 Typical pack sizes: Laboratory scale: 100 g - 5 kg PE bottle Industrial scale: 5 kg - 50 kg in double lined PE bags inside metal drum Larger pack sizes on request Other particle and pore size combinations on request. Examples of existing customised material: TAS08S11, TOS12S11 Application Data by courtesy of YMC Co., Ltd.

11 11 Other available brochures: YMC*Gel HG-series brochure (36 p.) YMC-BioPro prep brochure (16 p.) YMC*Gel HG-series High grade silica phases for preparative HPLC The Selectivity Company YMC-BioPro IEX materials Prep Bulk media YMC-Triart for AQ applications (16 p.) Purification of Insulin with C8 (16 p.) Trademarks Daisogel is a trademark of Daiso Co., Ltd. Kromasil ia a trademark of Akzo Nobel, Separation Products.

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